natgillin/translations-raw huggingface dataset:
• dizziness, taste disorders (dysgeusia), high blood pressure
• omotica, motnje okušanja (disgevzija), visok krvni tlak,
Abbreviations: ARR = adjudicated relapse rate; EDSS = Expanded Disability Status Scale; IST = immunosupressant therapy; Max = maximum; Min = minimum; NMOSD = neuromyelitis optica spectrum disorder; SD = standard deviation.
Okrajšave: ARR = pogostnost recidiva po strokovni presoji (adjudicated relapse rate); EDSS = razširjena lestvica stanja invalidnosti (Expanded Disability Status Scale); IST = imunosupresivna terapija; maks = maksimum; min = minimum;
The primary endpoint for Study ECU-NMO-301 was the time to first on-trial relapse as adjudicated by an independent committee who were blinded to treatment.
Primarni opazovani dogodek za študijo ECU-NMO-301 je bil čas do prvega recidiva med preskušanjem po presoji zaslepljenega neodvisnega odbora.
• fever (pyrexia), feeling tired (fatigue), influenza like illness
• zvišana telesna temperatura (pireksija), mrzlica, občutek utrujenosti (utrujenost), gripi podobna bolezen.
In aHUS Study C08-002A/B, the median duration of Soliris therapy was approximately100 weeks (range: 2 weeks to 145 weeks).
V študiji aHUS C08-002A/B je bilo mediano trajanje zdravljenja z zdravilom Soliris približno 100 tednov (razpon: 2 tedna do 145 tednov).
Patients who entered NMOSD clinical trials while receiving background immunosuppressant therapy continued treatment with immunosuppressant therapy while on Soliris treatment (See section 5.3).
Bolniki vključeni v klinična preskušanja NMOSD, ki so prejemali osnovno imunosupresivno zdravljenje, so med zdravljenjem z zdravilom Soliris nadaljevali z zdravljenjem z imunosupresivno terapijo (glejte poglavje 5.3).
A second population PK analysis with a standard 1 compartmental model was conducted on the multiple dose PK data from 37 aHUS patients receiving the recommended Soliris regimen in studies C08-002A/B
Farmakokinetična analiza druge populacije s standardnim modelom z 1 razdelkom je bila narejena na FK podatkih večkratnih odmerkov pri 37 bolnikih z aHUS, ki so prejemali priporočeno shemo zdravljenja z zdravilom Soliris v študijah C08-002A/B in C08-003A/B.
(≥1/1,000 to <1/100)
Občasni (≥ 1/1.000 do < 1/100)
Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.1).
Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.1).
* Immunosuppressant's included, but are not limited to, corticosteroids, azathioprine, mycophenolate, methotrexate , cyclosporine, tacrolimus, or cyclophosphamide.
* Imunosupresivna zdravila so med drugim vključevala tudi kortikosteroide, azatioprin, mikofenolat, metotreksat, ciklosporin, takrolimus ali ciklofosfamid.
Soliris is a clear and colorless solution.
Zdravilo Soliris je bistra in brezbarvna raztopina.
• destruction of red blood cells (haemolysis), clumping of cells, abnormal clotting factor, abnormal blood clotting,
• razkroj rdečih krvničk (hemoliza), zlepljanje celic, nenormalni faktorji strjevanja krvi, nenormalno strjevanje krvi,
Twenty-two (22) (17.6%) elderly refractory gMG patients (> 65 years of age) were treated with Soliris in the clinical trials.
V kliničnih preskušanjih so z zdravilom Soliris zdravili dvaindvajset (22) (17,6 %) starejših bolnikov z refraktarno gMG (starost > 65 let).
In all clinical studies, the most serious adverse reaction was meningococcal sepsis which is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.4).
V vseh kliničnih študijah je bil najbolj resen neželeni učinek meningokokna sepsa, s katero se pogosto začnejo meningokokne okužbe pri bolnikih, zdravljenih z zdravilom Soliris (glejte poglavje 4.4).
Abscess includes the following group of PTs: Abscess limb, Colonic abscess, Renal abscess, Subcutaneous abscess, Tooth abscess, Hepatosplenic abscess, Perirectal abscess, Rectal abscess.
a Absces vključuje naslednjo skupino prednostnih izrazov: absces uda, absces debelega črevesa, ledvični absces, podkožni absces, zobni absces, absces jeter in vranice, perirektalni absces, rektalni absces.
• Enrolment in the PNH and aHUS registries.
• vključitev v register bolnikov s PNH in aHUS.
In Study C10-003, patients who enrolled in the study were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH above the upper limits of normal and serum creatinine level ≥97 percentile for age without the need for chronic dialysis.
V študiji C10-003 so morali bolniki, ki so bili vključeni v študijo, imeti število trombocitov < od spodnje meje normalnega razpona (LLN), znake hemolize, npr. zvišanje serumske LDH nad zgornjo mejo normalne vrednosti in raven serumskega kreatinina ≥ 97 percentilov za starost, brez potrebe po kronični dializi.
In patients with gMG, their muscles can be attacked and damaged by the immune system which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk for aspiration, and markedly impaired activities of daily living.
Pri bolnikih z gMG lahko imunski sistem napade in poškoduje njihove mišice, kar lahko povzroči izrazito šibkost mišic, zmanjšano gibljivost, zasoplost, skrajno utrujenost, nevarnost aspiracije in znatno prizadete aktivnosti vsakdanjega življenja.
A total of 35 patients received PE/PI prior to eculizumab.
Vsega skupaj 35 bolnikov je pred ekulizumabom prejelo PE/PI.
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 g/dL or a decrease of >4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Resno hemolizo označujejo ravni LDH v serumu, višje od ravni pred zdravljenjem, v povezavi s katerimkoli od naslednjih znakov: absolutno zmanjšanje velikosti klona PNH za več kot 25 % (ob odsotnosti razredčenja zaradi transfuzije) v času enega tedna ali manj; raven hemoglobina < 5 g/dl ali zmanjšanje za > 4 g/dl v času enega tedna ali manj; angina;
Meningococcal infection includes the following group of PTs: Meningococcal infection, Meningococcal sepsis, Meningitis meningococcal, Neisseria infection.
b Meningokokna infekcija vključuje naslednjo skupino prednostnih izrazov: meningokokna infekcija, meningokokna sepsa, meningokokni meningitis, okužba z bakterijo Neisseria.
• The risk of developing antibodies to eculizumab.
• obstaja tveganje za nastanek protiteles proti ekulizumabu,
In patients with aHUS treated with Soliris, antibodies to Soliris were detected in 3/100 (3%) by the ECL bridging format assay.
Pri bolnikih z aHUS, zdravljenih z zdravilom Soliris, so protitelesa proti zdravilu z elektrokemiluminiscentno (ECL) premostitveno metodo zaznali pri 3/100 (3 %).
Table 5: Patient Demographics and Characteristics in C08-002A/B and C08-003A/B
Preglednica 5: Demografske in druge značilnosti bolnikov v študijah C08-002A/B in C08-003A/B
Haematologic normalization was defined as normalization of platelet counts and LDH levels sustained for ≥2 consecutive measurements for ≥4 weeks.
Hematološka normalizacija je bila definirana kot normalizacija števila trombocitov in stabilna raven LDH ob ≥ 2 zaporednih meritvah v ≥ 4 tednih.
Complete TMA response, n (%) Median duration of complete TMA response, weeks (range) 1
popoln TMA odgovor, n (%) mediano trajanje popolnega TMA odgovora, tedni (razpon)1
The second population PK model was applied to the multiple dose PK data from 22 paediatric aHUS patients receiving the recommended Soliris regimen in aHUS C10-003.
Drugi model populacijske farmakokinetike so uporabili za FK podatke večkratnih odmerkov, ki so jih pridobili pri 22 pediatričnih bolnikih z aHUS, ki so prejemali zdravilo Soliris po priporočeni shemi v študiji aHUS C10-003.
Dilute Soliris to a final concentration of 5 mg/ml by addition to the infusion bag using sodium chloride 9 mg/ml (0.9%) solution for injection, sodium chloride 4.5 mg/ml (0.45%) solution for injection, or 5% dextrose in water, as the diluent.
Zdravilo Soliris razredčite do končne koncentracije 5 mg/ml z dodajanjem 9 mg/ml (0,9-%) raztopine natrijevega klorida za injiciranje, 4,5 mg/ml (0,45-%) raztopine natrijevega klorida za injiciranje ali
Soliris can block the body's inflammatory response, and its ability to attack and destroy its own eye nerves and spinal cord, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living.
Zdravilo Soliris lahko zavre vnetni odziv telesa in njegovo sposobnost, da napada in uničuje svoje lastne očesne živce in hrbtenjačo, s čimer zmanjšuje simptome bolezni in vpliv bolezni na aktivnosti vsakdanjega življenja.
Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant IST treatment.
Bolniki, zdravljeni z zdravilom Soliris, so imeli podobno izboljšanje v času do prvega recidiva med preskušanjem po presoji strokovnega odbora bodisi s sočasnim zdravljenjem z IST bodisi brez njega.
Patients that were previously treated with Soliris in Study ECU-MG-301 continued to demonstrate a sustained effect of Soliris on all measures (MG-ADL, QMG, MGC and MG-QoL15) over an additional 52 weeks of treatment with Soliris.
Bolniki, ki so se predhodno v študiji ECU-MG-301 zdravili z zdravilom Soliris, so še naprej kazali trajen učinek zdravila Soliris na vsa merila (MG-ADL, QMG, MGC in MG-QoL15) še dodatnih
• The diluted solution should be allowed to warm to room temperature [18°C - 25°C] prior to administration by exposure to ambient air.
• Pred uporabo razredčeno raztopino izpostavite temperaturi v okolici in počakajte, da se ogreje na sobno temperaturo [18 °C - 25 °C].
• Treatment with eculizumab increases the risk of severe infection, especially Neisseria meningitidis and other Neisseria species, including disseminated gonorrhoeae.
• zdravljenje z ekulizumabom zveča tveganje za hude okužbe, zlasti z bakterijo Neisseria meningitidis in drugimi vrstami Neisseria species, vključno z diseminirano gonorejo,
The final volume of a 5 mg/ml diluted solution is 60 ml for 300 mg doses, 120 ml for 600 mg doses, 180 ml for 900 mg doses and 240 ml for 1,200 mg doses.
Končni volumen 5 mg/ml razredčene raztopine je 60 ml za 300 mg odmerke, 120 ml za 600 mg odmerke, 180 ml za 900 mg odmerke ali 240 ml za 1.200 mg odmerke.
After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Po redčenju je končna koncentracija raztopine, pripravljene za infundiranje, 5 mg/ml.
PNH Laboratory Monitoring
Laboratorijsko spremljanje bolnikov s PNH
At 26-weeks
26. tedna
Table 3: Efficacy Outcomes in C04-001 and C04-002 C04-001
Preglednica 3: Izidi učinkovitosti v študijah C04-001 in C04-002
Soliris was administered as an intravenous infusion over 25 - 45 minutes.
Zdravilo Soliris je bilo aplicirano v obliki 25-45-minutne intravenske infuzije.
To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection.
Za zmanjšanje tveganja okužbe morajo biti vsi bolniki cepljeni vsaj 2 tedna pred začetkom prejemanja zdravila Soliris, razen če tveganje odložitve zdravljenja z zdravilom Soliris odtehta tveganja razvoja meningokokne okužbe.
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.
V nekontrolirani študiji C04-002 (SHEPHERD) so bolniki s PNH, ki so prejeli najmanj eno transfuzijo v zadnjih 24 mesecih in najmanj 30.000 trombocitov na mikroliter, prejemali zdravilo
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).
V študiji C04-001 (TRIUMPH) so bili bolniki s PNH z vsaj 4 transfuzijami v preteklih 12 mesecih, z najmanj 10 % celic PNH, kar je bilo potrjeno s pretočno citometrijo, ter najmanj 100.000 trombociti na mikroliter randomizirani bodisi na zdravljenje z zdravilom Soliris (n = 43) ali na prejemanje placeba (n = 44).
Supportive safety data were obtained from 30 completed and one ongoing clinical studies that included 1,503 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG and NMOSD.
Podporne podatke o varnosti so pridobili iz 30 zaključenih kliničnih študij in ene klinične študije v teku, v katere so bili vključeni 1.503 bolniki, ki so bili izpostavljeni ekulizumabu v skupinah bolezni, posredovanih s komplementom, vključno s PNH, aHUS, refraktarno gMG in NMOSD.
Soliris is indicated in adults and children for the treatment of: - Paroxysmal nocturnal haemoglobinuria (PNH).
Zdravilo Soliris je indicirano pri odraslih in otrocih za zdravljenje: - paroksizmalne nočne hemoglobinurije (PNH).
Mean Age (SD)
povprečje (SD)
If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice.
Če ste uporabili večji odmerek zdravila Soliris, kot bi smeli Če domnevate, da ste po pomoti prejeli večji odmerek zdravila Soliris od predpisanega, se posvetujte z zdravnikom.
After completion of the initial 26-week treatment period, most patients continued to receive Soliris by enrolling into an extension study.
Po zaključenem začetnem 26-tedenskem obdobju zdravljenja je večina bolnikov nadaljevala zdravljenje z zdravilom Soliris in je bila vključena v podaljšek študije.
Use of Soliris in NMOSD treatment has been studied only in the setting of chronic administration and the effect of Soliris discontinuation has not been characterized.
Uporabo zdravila Soliris pri zdravljenju NMOSD so proučevali samo v okviru kronične uporabe in učinka prekinitve dajanja zdravila Soliris niso podrobno opredeljevali.
• skin tumor (melanoma), bone marrow disorder
• kožni tumor (melanom), bolezen kostnega mozga,
All patients enrolled in aHUS Study C10-004 had an ADAMTS-13 level above 5%.
Vsi bolniki, vključeni v študijo aHUS C10-004, so imeli raven ADAMTS-13 nad 5 %.
• inflammation of the skin, skin color disorder
• vnetje kože, sprememba barve kože,
What Soliris looks like and contents of the pack Soliris is presented as a concentrate for solution for infusion (30 ml in a vial - pack size of 1).
Zdravilo Soliris je na voljo kot koncentrat za pripravo raztopine za infundiranje (30 ml v vialipakiranje po 1 vialo).
Adverse reactions reported in patients with disease other than PNH, aHUS, refractory gMG or NMOSD were similar to those reported in patients with PNH, aHUS, refractory gMG or NMOSD (see Table 1 above).
Neželeni učinki, o katerih so poročali pri bolnikih z drugimi boleznimi, ki niso PNH, aHUS, refraktarna gMG ali NMOSD, so bili podobni tistim, o katerih so poročali pri bolnikih s PNH, aHUS, refraktarno gMG ali NMOSD (glejte preglednico 1).
Soliris can block the body's inflammatory response, and its ability to attack and destroy its own muscles to improve muscle contraction, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living.
Zdravilo Soliris lahko prepreči vnetni odziv telesa in njegovo sposobnost, da napada in uničuje svoje lastne mišice, s čimer se izboljša krčenje mišic, s tem pa se zmanjšajo tudi bolezenski simptomi in vpliv bolezni na aktivnosti vsakdanjega življenja.
Historical Annualized Relapse Rate within 24 months prior to Screening
preračunana na eno leto, v 24 mesecih pred presejanjem povprečje
In patients with NMOSD, their eye nerve and spinal cord are attacked and damaged by the immune system which can lead to blindness in one or both eyes, weakness or paralysis in the legs or arms, painful spasms, loss of sensation, and markedly impaired activities of daily living.
Pri bolnikih z NMOSD imunski sistem napade in poškoduje očesne živce in hrbtenjačo, kar lahko povzroči slepoto enega ali obeh oči, oslabelost ali ohromelost zgornjih ali spodnjih udov, boleče mišične spazme, izgubo občutkov in znatno zmanjšanje aktivnosti vsakdanjega življenja.
At least 2 weeks before you start treatment with Soliris, your doctor will administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated.
Vsaj 2 tedna pred začetkom zdravljenja z zdravilom Soliris vas bo zdravnik cepil proti meningokokni okužbi, če še niste bili cepljeni ali če cepljenje ne učinkuje več.
• Dilute Soliris to a final concentration of 5 mg/ml (initial concentration divided by 2) by adding the appropriate amount of diluent to the infusion bag.
• Zdravilo Soliris razredčite do končne koncentracije 5 mg/ml (začetna koncentracija, deljena z dva)
In a NMOSD placebo controlled study, 2/96 (2%) of the Soliris treated patients showed antidrug antibody response post-baseline.
V s placebom kontrolirani študiji NMOSD sta 2/96 (2 %) bolnikov, zdravljenih z zdravilom Soliris,
Table 12: Patient Disease history and Baseline Characteristics in Study ECU-NMO-301 Variable
Preglednica 12: Anamneza bolezni in osnovne značilnosti bolnikov v študiji ECU-NMO-301 Spremenljivka
Fresh frozen plasma infusion
Infuzija sveže zmrznjene plazme
Children and adolescents with PNH or aHUS and who are under 40 kg weight require a lower dose based on how much they weigh.
Otroci in mladostniki s PNH in aHUS in tisti s telesno maso manj kot 40 kg potrebujejo manjše odmerke, ki so izračunani na osnovi njihove telesne mase.
In paediatric patients with shorter duration of current severe clinical thrombotic microangiopathy (TMA) manifestation prior to eculizumab, there was TMA control and improvement of renal function with eculizumab treatment (Table 15).
Pri pediatričnih bolnikih s krajšim trajanjem nedavne resne manifestacije trombotične mikroangiopatije (TMA) pred ekulizumabom je prišlo ob zdravljenju z ekulizumabom do nadzora TMA in izboljšanja ledvične funkcije (preglednica 15).
P - Value Mean (SD) Wilcoxon Signed Rank
Povprečje (SD) Wilcoxonov predznačen rang Parni t-test
Eculizumab can block the body's inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.
Ekulizumab lahko blokira vnetni odziv telesa in njegovo zmožnost, da napada in uničuje svoje lastne občutljive krvne celice PNH.
Supportive safety data were obtained in 12 completed clinical studies that included 934 patients exposed to eculizumab in other disease populations other than PNH, aHUS, refractory gMG or NMOSD.
Podporni podatki o varnosti so bili pridobljeni v 12 zaključenih kliničnih študijah, v katerih je bilo ekulizumabu izpostavljenih 934 bolnikov iz drugih skupin bolezni, ki niso PNH, aHUS, refraktarna gMG ali NMOSD.
aHUS Laboratory Monitoring aHUS patients receiving Soliris therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Bolnike z aHUS, ki prejemajo zdravilo Soliris, je treba nadzirati glede trombotične mikroangiopatije z določanjem števila trombocitov, serumske LDH in serumskega kreatinina ter po potrebi prilagoditi odmerek v okviru priporočene sheme odmerjanja 14 ± 2 dni med fazo vzdrževanja (največ vsakih 12 dni).
Additionally, all patients must be vaccinated against meningococcal infections at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection.
Poleg tega morajo biti vsi bolniki cepljeni proti meningokoknim okužbam vsaj 2 tedna pred začetkom prejemanja zdravila Soliris, razen če tveganje odložitve zdravljenja z zdravilom Soliris odtehta tveganja razvoja meningokokne okužbe.
• Patient's/carer's information brochures
• vodnik z informacijami za bolnike/skrbnike,
Chronic administration of Soliris results in immediate, complete, and sustained inhibition of terminal complement activity.
Kronična uporaba zdravila Soliris povzroči takojšnjo, popolno in trajno zavrtje aktivnosti terminalnega komplementa.
If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician.
Če pride med dajanjem zdravila Soliris do neželenega dogodka, je mogoče po presoji zdravnika infuzijo upočasniti ali ustaviti.
*See paragraph Description of selected adverse reactions.
verzija 21.0 MedDRA. *Glejte odstavek Opis izbranih neželenih učinkov.
A total of 10 patients received PE/PI prior to eculizumab.
Vsega skupaj 10 bolnikov je pred ekulizumabom prejelo PE/PI.
The aHUS, refractory gMG and NMOSD dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase:
(gMG) in specifični obliki nevromielitisa vidnega živca (NMOSD): Shema odmerjanja za aHUS, refraktarno gMG in NMOSD pri odraslih bolnikih (≥ 18 let starosti) je sestavljena iz 4-tedenske začetne faze, ki ji sledi faza vzdrževanja:
The primary analysis of the QMG was a Worst-Rank ANCOVA with a mean rank of 54.7 for Soliris and 70.7 for placebo, based on 125 study patients (p=0.0129).
ANCOVA s povprečnim rangom 54,7 za zdravilo Soliris in 70,7 za placebo na podlagi 125 bolnikov, vključenih v študijo (p = 0,0129).
No specific studies have been performed to evaluate the hepatic, renal, lung, or gastrointestinal routes of excretion/elimination for Soliris.
Izvedena ni bila nobena specifična študija, s katero bi ocenili poti izločanja/odstranjevanja zdravila Soliris iz telesa preko jeter, ledvic, pljuč ali prebavil.
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.
V primeru resne hemolize po prekinitvi zdravljenja z zdravilom Soliris razmislite o naslednjih postopkih/načinih zdravljenja: transfuzija krvi (koncentriranih eritrocitov) ali izmenjalna transfuzija, če je eritrocitov PNH > 50 % vseh eritrocitov (izmerjeno s pretočno citometrijo); antikoagulacija;
Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take 25 - 45 minutes.
Vsaka infuzija bo vsebovala odmerek 600 mg (2 viali po 30 ml) in bo trajala 25-45 minut.
In Study ECU-MG-301, a clinical responder in the QMG total score was defined as having at least a 5point improvement.
V študiji ECU-MG-301 je bil bolnik, ki se je klinično odzval na zdravljenje, kar zadeva celotni rezultat QMG, opredeljen kot bolnik z izboljšanjem za vsaj 5 točk.
weeks to 86 weeks).
50 tednov (razpon: od 13 tednov do 86 tednov).
b
P
Cases of thrombotic microangiopathy complication have been reported in the setting of missed or delayed Soliris dose in aHUS clinical trials (see also Section 4.4).
Poročali so o primerih zapleta trombotične mikroangiopatije pri izpuščenem odmerku ali nepravočasnem dajanju odmerka zdravila Soliris v kliničnih preskušanjih aHUS (glejte tudi poglavje 4.4).
Hepatic impairment The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Varnost in učinkovitost zdravila Soliris pri bolnikih z okvaro jeter ni bila preučena.
If you stop using Soliris for aHUS
Če ste prenehali uporabljati zdravilo Soliris za aHUS
− The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
- Učinkovina je ekulizumab (300 mg/30 ml v viali, kar ustreza 10 mg/ml).
Number of PE/PI sessions for current clinical TMA manifestation, median (min, max)
Število terapij PE/PI za nedavno klinično izražene TMA, mediana (min, maks)
Infusion Reactions
Reakcije na infuzijo
Withdrawal of immunosuppressant therapy during Soliris treatment for NMOSD has not been assessed.
Ukinitve imunosupresivnega zdravljenja med zdravljenjem NMOSD z zdravilom Soliris niso ocenjevali.