natgillin/translations-raw huggingface dataset:
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C in normal light conditions, and for 24 hours at 2°C to 8°C when protected from light. 
Kemična in fizikalna stabilnost koncentrata sta dokazani za 24 ur pri temperaturi 25 ± 2 °C v normalnih svetlobnih pogojih in za 24 ur pri temperaturi od 2 do 8 °C, če je zaščiten pred svetlobo.
gastrointestinal perforation Hepatobiliary disorders Common: 
Pogostnost neznana gastrointestinalna perforacija
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2). 
2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
- Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections. 
zvišana telesna temperatura resno poslabšanje splošnega stanja lokalni simptomi, npr. vnetje žrela ali pekoč občutek pri uriniranju hude bolečine v trebuhu, zvišana telesna temperatura in driska (ki je v redkih primerih krvava) so lahko znaki vnetja črevesa (nevtropeničnega kolitisa)
ITT population Cisplatin 50 mg/m2 on day 1, every 21 days 
cisplatin 50 mg/m2 na 1. dan vsakih 21 dni cisplatin 50 mg/m2 na 1. dan +
Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml. 
Ustrezno količino tako pripravljene raztopine je treba še dodatno razredčiti bodisi z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml)ali s 5-odstotno (m/v) raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride). 
Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1 mg topotekana (v obliki klorida).
Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride). 
Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 4 mg topotekana (v obliki klorida).
Each vial contains 1 mg topotecan (as hydrochloride). 
Ena viala vsebuje 1 mg topotekana (kot klorida).
In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % 
Ob hudi nevtropeniji so med prvim ciklusom zdravljenja pri 16 % bolnikov opazili zvišano telesno temperaturo ali okužbo, 23 % bolnikov pa je imelo takšne neželene učinke ves čas (v 6 % ciklusov zdravljenja).
Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions. 
Kemična in fizikalna stabilnost raztopine po redčenju koncentrata z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za infundiranje je dokazana za 4 ure pri temperaturi 25 ± 2 °C v normalnih svetlobnih razmerah.
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %). 
bruhanje (32 %), driska (18 %), zaprtje (9 %) in vnetje ustne sluznice (14 %).
Powder for concentrate for solution for infusion. 
koncentrat za raztopino za infundiranje.
− Personnel should be trained to reconstitute and dilute the the medicinal product. 
Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
Each vial contains 4 mg topotecan (as hydrochloride). 
Ena viala vsebuje 4 mg topotekana (kot klorida).
Hepatic impairment 
splošno slabo počutje
Ovarian and small cell lung carcinoma 
Karcinom jajčnika in drobnocelični pljučni karcinom Začetni odmerek
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion 
Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje
pruritus 
srbenje
Yellow lyophilisate. 
Okvara ledvic
Before infusion, Potactasol powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows: - Potactasol 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Potactasol 4 mg with 4 ml water for injections Reconstitution will result in a concentrate containing 1 mg topotecan per ml. 
- Potactasol 1 mg z 1,1 ml vode za injekcije (ker vsebuje 10 % prepolnjenja) - Potactasol 4 mg s 4 ml vode za injekcije
Mannitol (E421) Tartaric acid (E334) Sodium hydroxide Hydrochloric acid (E507) 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) vinska kislina (E334) natrijev hidroksid klorovodikova kislina (E507)
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively. 
Hude oblike (3. ali 4. stopnje) motenj so ugotavljali z naslednjimi pogostnostmi: navzea (4 %), bruhanje (3 %), driska (2 %) in vnetje ustne sluznice (1 %).
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary). 
Pred naslednjo uporabo topotekana mora biti število nevtrofilcev ≥ 1,5 x 109/l, število trombocitov ≥ 100 x 109/l in vrednost hemoglobina ≥ 9 g/dl (po prejemu transfuzije,če je ta potrebna).
Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation). 
Pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) hude bolečine v trebuhu, občutek slabosti, bruhanje krvi, črno ali krvavo blato (to so lahko simptomi gastrointestinalne perforacije ali predrtja stene prebavil),
In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively. 
Stopnja odzivnosti na zdravljenje (95-odstotni interval zaupanja) je znašala 20,5 % (13 %, 28 %) oziroma 14 % (8 %, 20 %), mediana časa do napredovanja pa 19 tednov za topotekan in 15 tednov za paklitaksel (razmerje ogroženosti 0,7 [0,6, 1,0]).
The following information is intended for healthcare professionals only: 
Informacije namenjene samo zdravstvenemu osebju: Potactasol
Effective contraception methods should be used to avoid becoming pregnant or fathering a child while on treatment with Potactasol. 
Uporabljati morate učinkovito kontracepcijo zaščito, da v času zdravljenja z zdravilom
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan 
Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
Potactasol is not recommended in case of severe kidney impairment; - if you have liver problems. 
Zdravila Potactasol ni priporočljivo uporabljati pri bolnikih s hudo okvaro ledvic.
One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1). 
pri katerih je prišlo do ponovitve ≥ 90 dni po koncu ene predhodne sheme kemoterapije, so izvedli eno študijo faze II (Študija 065) in eno študijo faze III (Študija 396) (glejte preglednico 1).
When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n = 9) and Cmax (23 %, n = 11) was noted on day 5. 
13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (za 12%, n = 9) in Cmax
Potactasol 4 mg powder for concentrate for solution for infusion topotecan 
Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). 
- bolnikih s ponovitvijo drobnoceličnega pljučnega raka, pri katerih ponovno prve linije ni primerno (glejte poglavje 5.1).
Relapsed ovarian cancer 
Ponovitev drobnoceličnega pljučnega raka
Potactasol 1 mg powder for concentrate for solution for infusion topotecan 
Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje topotekan
anaphylactic reaction angioedema urticaria 
zvišana telesna temperatura astenija utrujenost
In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group. 
Pri bolnikih s ponovitvijo dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24,3 %, na kombinacijo CAV pa 18,3 %.
Not known: 
Pogostnost neznana:
How to store Potactasol 
Dajanje zdravila Potactasol
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
Previdnostni ukrepi pred ravnanjem z zdravilom in njegovo uporabo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton 
ekstravazacija3 Pogostnost neznana vnetje sluznice
Blood and lymphatic system disorders Very common: 
Bolezni krvi in limfatičnega sistema
The mean metabolite:parent AUC ratio was < 10 % for both total topotecan and topotecan lactone. 
Tako za celotni topotekan kot za topotekan lakton je srednje razmerje med vrednostima AUC presnovka in matične učinkovine manjše od 10 %.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN UPORABE
Potactasol INSTRUCTIONS ON USE 
B. NAVODILO ZA UPORABO
mucosal inflammation 
vnetje ustne sluznice
The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan, as Potactasol 1 mg contains a 10 % overage of fill. 
Ker vsebuje zdravilo Potactasol 10% prebitek, ima nastala bledo rumena raztopina koncentracijo 1 mg topotekana na ml.
- Fever. 
- Zvišana telesna temperatura.
How Potactasol is prepared 
Priprava zdravila Potactasol
At the end of this period the product can be put back in the refrigerator. 
Na koncu tega obdobja lahko zdravilo vrnete nazaj v hladilnik.
5 Wald confidence interval. 
5 Waldov interval zaupanja.
The majority (90.9%) of patients were female. 
Večina (90,9 %) bolnikov je bila ženskega spola.
Your doctor will calculate this. 
To bo izračunal vaš zdravnik.
Safety Data from Other Clinical Studies 
Podatki o varnosti iz drugih kliničnih študij
p-value (using repeated measures analysis) 
Vrednost p (z uporabo analize ponovljenih meritev)
However, due to the lack of wellcontrolled studies, uncertainties remain. 
Vendar zaradi pomanjkanja dobro kontroliranih študij negotovosti ostajajo.
Approximately half were White (49.0%). 
Približno pol jih je bilo belcev (49,0 %).
No substantial differences were seen in safety and efficacy related to age. 
Znatnih razlik v varnosti in učinkovitosti, povezanih s starostjo, ni bilo.
However, chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C. 
Vendar pa je bila dokazana kemična in fizikalna stabilnost za čas 24 ur pri temperaturi med 2 °C in 8 °C.
As with all proteins there is a potential for immunogenicity. 
Kot pri vseh beljakovinah obstaja možnost za pojav imunogenosti.
Fatigue and health-related quality of life were relevant secondary endpoints. 
Utrujenost in z zdravjem povezana kakovost življenja sta bili relevantni sekundarni končni stanji.
Store in a refrigerator (2°C - 8°C). 
Shranjujte v hladilniku (2 °C - 8 ºC).
Patients with other diseases 
Bolniki z drugimi boleznimi
The safety profiles in the different paediatric subsets of age appear similar. 
Varnostni profili pri različnih pediatričnih starostnih podskupinah so se zdeli podobni.
Pontevedra 36400 
Pontevedra 36400 Španija
This card is named: “Patient Safety Card”. 
Ta kartica se imenuje: »opozorilna kartica za bolnika«.
1 Based on the Kaplan-Meier product limit method. 
1 Na podlagi Kaplan-Meierjeve metode ‘product limit'.
Patients reported improved health-related quality of life (QoL). 
Bolniki so poročali o izboljšanju kakovosti življenja (QoL).
Instructions: 
Navodila:
Following each infusion, you will be monitored for about one hour. 
Po vsaki infuziji bodo vaše stanje spremljali približno eno uro.
Responses were similar across all ages from 5 months to 17 years of age. 
Odziv je bil podoben pri vseh starostih od 5 mesecev do 17 let starosti.
You should also be aware that vaccination may not prevent this type of infection. 
Vendar pa se morate zavedati dejstva, da cepljenje morda ne bo preprečilo tovrstne okužbe.
TMA interventions were defined as PE/PI or new dialysis. 
Intervencije TMA so bile definirane kot PE/PI ali nova dializa.
- sensitivity to light 
- občutljivost za svetlobo.
Soliris No transfusion 
Soliris Brez transfuzije
Practical advice should be included to mitigate the risk. 
Vključeni naj bodo praktični nasveti za zmanjšanje tveganja,
Vaccination may not be sufficient to prevent meningococcal infection. 
Cepljenje morda ne bo zadostovalo za preprečevanje meningokokne okužbe.
However, this finding was shown in non-controlled clinical trials. 
Vendar pa se je ta ugotovitev pokazala pri nekontroliranih kliničnih preskušanjih.
Type of Plasma Intervention 
Vrsta intervencije s plazmo
Physicians should advise patients about gonorrhoea prevention. 
Zdravniki morajo svetovati bolnikom glede preprečevanja gonoreje.
Other Systemic Infections 
Druge sistemske okužbe
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. 
Ni dokazov, da bi bili pri zdravljenju starejših ljudi potrebni posebni previdnostni ukrepi - čeprav so izkušnje z zdravilom Soliris pri tej populaciji bolnikov še vedno omejene.
Percentage of patients with stabilized Haemoglobin levels at end of study 
Odstotek bolnikov s stabilizirano ravnijo hemoglobina ob koncu študije
Should such a treatment be considered necessary during pregnancy, a close maternal and foetal monitoring according to local guidelines is recommended. 
Če se oceni, da je takšno zdravljenje med nosečnostjo potrebno, je priporočljivo skrbno spremljanje matere in ploda v skladu z lokalnimi smernicami.
Your doctor's instructions should be carefully observed. 
Navodila zdravnika pozorno upoštevajte.
Total number of patient-years in study period n 
Skupno število bolnikovih let v času študije n
This leaflet was last revised in. 
Navodilo je bilo nazadnje revidirano.
The patient safety card should contain: 
Opozorilna kartica za bolnika mora vsebovati:
Patients must receive vaccination according to current national vaccination guidelines for vaccination use. 
Bolniki morajo biti cepljeni v skladu z veljavnimi nacionalnimi smernicami za cepljenje.
4 Based on a stratified Cox proportional hazards model. 
4 Na podlagi stratificiranega Coxovega modela proporcionalnih tveganj.
Positive ADA samples were low titer and transient. 
Pozitivni vzorci ADA so imeli nizek titer in so bili prehodni.
• All patients must be monitored for signs of meningococcal infection. 
• vse bolnike je treba spremljati za znake meningokoknih okužb,
Smithfield, Rhode Island 02917 
Smithfield, Rhode Island 02917 ZDA
2 Based on the complementary log-log transformation. 
2 Na podlagi komplementarne transformacije log-log.
If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. 
Če se pri vas pojavi kateri od zgoraj navedenih simptomov, vzemite antibiotike, kot vam je bilo predpisano.
• Maintenance Phase: 
• Faza vzdrževanja:
You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics. 
Vendar pojdite čim prej k zdravniku, tudi če se po zaužitju antibiotikov počutite bolje.
• Contact details where a health care practitioner can receive further information. 
• kontaktne podatke, kamor se lahko zdravstveni delavec obrne za dodatne informacije.
• Statement that the patient is receiving eculizumab. 
• izjavo, da bolnik prejema ekulizumab,
There are no well-controlled studies in pregnant women treated with eculizumab. 
Ni dobro kontroliranih študij pri nosečnicah, zdravljenih z ekulizumabom.
- polysorbate 80 (vegetable origin) 
− polisorbat 80 (rastlinskega izvora)
>2 months 
> 2 meseca
1 month to <12 years 
Parameter od 1 mesec do < 12 let
Very common: may affect more than 1 in 10 people: headache. 
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov: glavobol.
• yellowing of the skin and/or eyes (jaundice) 
• porumenelost kože in/ali oči (zlatenica),
Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people. 
Zdravilo Soliris vsebuje beljakovino, beljakovine pa lahko pri nekaterih ljudeh povzročijo alergijske reakcije.
Efficacy outcomes for the pre-specified repeated measures analyses of the primary and secondary endpoints are provided in Table 10. 
Izidi učinkovitosti za analize vnaprej opredeljenih ponovljenih meritev primarnih in sekundarnih opazovanih dogodkov so v preglednici 10.
3 Based on a stratified log-rank test. 
3 Na podlagi stratificiranega testa log-rank.
Table 11 presents an overview of the patients reporting clinical deterioration and patients requiring rescue therapy over the 26 weeks. 
Preglednica 11 kaže pregled bolnikov, ki so poročali o kliničnem poslabšanju, in bolnikov, ki so potrebovali rešilno zdravljenje v teh 26 tednih.
Your doctor will want to monitor you closely for at least 8 weeks. 
Zdravnik bo želel vsaj 8 tednov podrobneje spremljati vaše stanje.
4- Special Handling and Storage 
4- Posebno ravnanje in shranjevanje
Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients. 
Sočasno uporabljana zdravila so vključevala antitrombotike pri 63 % bolnikov in sistemske kortikosteroide pri 40 % bolnikov.
Discontinuation of treatment should only be considered if medically justified. 
Prekinitev zdravljenja pride v poštev le, če je medicinsko upravičena.
The bulk drug substance manufacturing process also includes specific viral inactivation and removal steps. 
Proces proizvodnje osnovne učinkovine vključuje tudi specifične postopke inaktivacije in odstranitve virusov.
The clearance and half-life of eculizumab were also evaluated during plasma exchange interventions. 
Očistek in razpolovni čas ekulizumaba sta bila ocenjena tudi med intervencijami z izmenjavo plazme.
Supplemental Soliris Dose With Each PE/PI Intervention 
Dodaten odmerek zdravila Soliris ob vsaki intervenciji s PE/PI
All patients included in the trial were refractory gMG patients and met the following predefined criteria: 
Vsi bolniki, vključeni v preskušanje, so bili bolniki z refraktarno gMG in so izpolnjevali naslednja vnaprej opredeljena merila:
No unexpected tissue cross-reactivity was observed. 
Ugotovljena ni bila nobena nepričakovana navzkrižna reaktivnost s tkivom.
1/100 (1%) aHUS patients had low positive values for neutralizing antibodies. 
1/100 (1 %) bolnikov z aHUS je imel nizke pozitivne vrednosti nevtralizirajočih protiteles.
In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event). 
Pri študiji SHEPHERD je 96 od 97 vključenih bolnikov dokončalo študijo (en bolnik je umrl zaradi trombotičnega zapleta).
Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis. 
Rekonstitucijo in redčenje je treba izvajati v skladu s pravili dobre prakse, še zlasti v zvezi z asepso.
These studies included assessment of fertility and early embryonic development, developmental toxicity, and pre and post-natal development. 
Te študije so vključevale oceno plodnosti in zgodnjega razvoja zarodka, toksičnosti za razvoj in prenatalnega in postnatalnega razvoja.
Both patients were negative for neutralizing antibodies. 
Oba bolnika sta bila negativna za nevtralizirajoča protitelesa.
Plasma exchange resulted in an approximately 50% decline in eculizumab concentrations following a 1 hour intervention and the elimination half-life of eculizumab was reduced to 1.3 hours. 
Izmenjava plazme je imela za posledico približno 50 % padec koncentracije ekulizumaba po enourni intervenciji in razpolovni čas odstranjevanja se je zmanjšal na 1,3 ure.
Available data suggest that clinical response is usually achieved by 12 weeks of Soliris treatment. 
Podatki, ki so na voljo, kažejo, da se klinični odziv navadno doseže v 12 tednih zdravljenja z zdravilom Soliris.
Maintenance Phase 
Faza vzdrževanja
Therefore, Soliris should be given to a pregnant woman only if clearly needed. 
Zato se sme zdravilo Soliris nosečnici dajati samo, če je to nedvomno potrebno.
After 3 weeks of Soliris treatment, patients reported less fatigue and improved health-related quality of life. 
Po 3 tednih zdravljenja z zdravilom Soliris so bolniki poročali o manjši utrujenosti in izboljšanju z zdravjem povezane kakovosti življenja.
Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately. 
Bolnike je treba obvestiti o teh znakih in simptomih ter ustreznih ukrepih, da bi lahko nemudoma poiskali medicinsko pomoč.
See Table 3. 
Glejte preglednico 3.
Clear, colorless, pH 7.0 solution. 
Bistra, brezbarvna raztopina s pH 7,0.
The median age at first dose of study drug was 45 years. 
Mediana starost v času prvega odmerka zdravila v kliničnem preskušanju je bila 45 let.
Basedow's disease 
Basedowova bolezen
All Patients (N = 22) 
vsi bolniki (N = 22)
Aspergillus infectionc, Arthritis bacterial c, 
Aspergillus c, bakterijski artritis c,
Date of latest renewal : 18 June 2012 
Datum prve odobritve: 20. junij 2007 Datum zadnjega podaljšanja: 18. junij 2012
For children and adolescents with PNH and aHUS aged less than 18 years: 
Za otroke in mladostnike s PNH in aHUS, mlajše od 18 let:
The most common adverse reaction reported in paediatric patients was headache. 
Najpogostejši neželeni učinek, o katerem so poročali pri pediatričnih bolnikih, je bil glavobol.
Therefore, an individual risk benefit analysis is recommended before starting and during treatment with eculizumab in pregnant women. 
Zato je priporočljiva analiza tveganja in koristi pri posamezni bolnici pred začetkom zdravljenja in med zdravljenjem nosečnic z ekulizumabom.
All rates of efficacy endpoints improved or were maintained through 2 years of treatment. 
Vse stopnje ciljev študije učinkovitosti so se izboljšale ali ostale nespremenjene ves čas dveletnega zdravljenja.
The most common reason for change in immunosuppressant therapy was improvement in MG symptoms while on eculizumab treatment. 
Najpogostejši razlog za spremembo imunosupresivnega zdravljenja je bilo izboljšanje simptomov MG med zdravljenjem z ekulizumabom.
The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues. 
Navzkrižna reaktivnost med ekulizumabom in tkivom je bila ocenjena z vrednotenjem vezave na panel 38 človeških tkiv.