natgillin/translations-raw huggingface dataset:
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).
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.
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.
No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab.
Študije na živalih, na podlagi katerih bi bilo mogoče oceniti genotoksični in karcinogeni potencial ekulizumaba, niso bile opravljene.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Datum: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Patients should be instructed that if they develop fever, headache accompanied with fever and/or stiff neck or sensitivity to light, they should immediately seek medical care as these signs may be indicative of meningococcal infection.
Bolnikom je treba naročiti, da morajo v primeru, če se pojavi vročina, glavobol, ki ga spremlja vročina, in/ali otrdel vrat ali občutljivost na svetlobo, nemudoma poiskati zdravniško pomoč, saj so lahko ti znaki pokazatelji meningokokne okužbe.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake »EXP«.
1) Failed treatment for at least one year with 2 or more immunosuppressant therapies (either in combination or as monotherapy), ie, patients continued to have impairment in activities of daily living despite immunosuppressant therapies
1) Neuspešno zdravljenje, ki je trajalo vsaj eno leto, z 2 ali več imunosupresivnimi zdravili (bodisi v kombinaciji bodisi kot monoterapija), t.j., bolniki so imeli še naprej težave pri aktivnostih vsakdanjega življenja kljub imunosupresivnim zdravilom ALI
If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor.
Če opazite kakšne simptome meningokokne okužbe (glejte poglavje 2 Opozorilo v zvezi z meningokoknimi okužbami in drugimi okužbami z bakterijami Neisseria), morate nemudoma obvestiti zdravnika.
2- Before Administration
2- Pred uporabo
Soliris is specifically indicated for patients who remain symptomatic despite treatment with other existing MG therapies.
Zdravilo Soliris je posebej indicirano za bolnike, pri katerih simptomi bolezni vztrajajo kljub zdravljenju z drugimi obstoječimi zdravili za MG.
Patients receiving anticoagulants and systemic corticosteroids at baseline continued these medications.
Bolniki, ki so predhodno prejemali antikoagulante in sistemske kortikosteroide, so nadaljevali z jemanjem teh zdravil.
No effects on the breastfed newborn / infant are anticipated as limited data available suggest that eculizumab is not excreted in human breast milk.
Ne pričakujemo učinkov na dojenega novorojenčka/dojenčka, ker omejeni podatki, ki so na voljo, kažejo, da se ekulizumab pri človeku ne izloča v materino mleko.
It also resulted in a marked decrease or elimination of blood transfusions, and a trend towards an overall improvement in general function.
Posledica zdravljenja je bilo tudi občutno zmanjšanje ali odsotnost potrebe po transfuziji krvi in trend proti celokupnemu izboljšanju splošnega stanja.
Data from 100 patients in four prospective controlled studies, three in adult and adolescent patients (C08
100 bolnikih v štirih prospektivnih kontroliranih študijah, treh pri odraslih in mladostniških bolnikih
Additional endpoints included TMA intervention rate, haematologic normalization, complete TMA response, changes in LDH, renal function and quality of life.
Dodatni končni cilji so vključevali delež intervencij TMA, hematološko normalizacijo, popoln TMA odgovor, spremembe LDH, ledvično funkcijo in kakovost življenja.
All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary.
Vse bolnike je treba nadzorovati glede zgodnjih znakov meningokokne okužbe, jih v primeru suma na okužbo nemudoma ovrednotiti ter jih po potrebi zdraviti z ustreznimi antibiotiki.
Pharmacokinetic Parameters
Farmakokinetični parametri
The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis.
Najpogostejši neželeni učinek je bil glavobol (ki se je pojavil večinoma v začetni fazi odmerjanja), najresnejši neželeni učinek pa je bila meningokokna sepsa.
Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
Ekulizumab ohrani prvotne komponente aktivacije komplementa, ki so bistvene za opsonizacijo mikroorganizmov in očistek imunskih kompleksov.
In this setting, a decrease of the daily dose of at least 1 immunosuppressant was observed in 47% of patients.
V teh razmerah so pri 47 % bolnikov opazili zmanjšanje dnevnega odmerka vsaj enega imunosupresivnega zdravila.
Subjects who undergo plasma exchange may receive additional doses of Soliris.
Osebe, ki prejmejo izmenjalno transfuzijo plazme, bodo morda potrebovali dodatne odmerke zdravila Soliris.
achieved hematologic normalization.
bolnikov) pa so dosegli hematološko normalizacijo.
No specific adverse reactions have emerged from these clinical studies.
V teh kliničnih študijah se niso pojavili specifični neželeni učinki.
Anticoagulant therapy Treatment with Soliris should not alter anticoagulant management.
Zdravljenje z zdravilom Soliris ne sme spremeniti antikoagulantne terapije.
At 26 weeks At 2 years1 At 26 weeks At 2 years1
pri 26 tednih pri 2 letih1
In PNH placebo controlled studies low antibody responses have been reported with a frequency (3.4%) similar to that of placebo (4.8%).
V študijah PNH, kontroliranih s placebom, so o odzivu z nizkim titrom protiteles poročali s pogostnostjo (3,4 %), podobno kot pri placebu (4,8 %).