Examples of using Soliris in English and their translations into Croatian
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Colloquial
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Ecclesiastic
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Computer
Other information about Soliris.
What Soliris is and what it is used for What is Soliris.
What is the risk associated with Soliris?
For Soliris, no clinical data on exposed pregnancies are available.
If you forget an appointment to receive Soliris.
Withdraw the required amount of Soliris from the vial(s) using a sterile syringe.
Instructions for Use for Healthcare Professionals Handling Soliris.
More Quality defect report to Soliris 300 mg concentrate for solution for infusion.
In PNH clinical studies,16 patients discontinued the Soliris treatment regimen.
Despite Soliris re-initiation following discontinuation, progression to end stage renal disease occurred in one patient.
Renal function, as measured by eGFR, was improved and maintained during Soliris therapy.
Soliris must be given under the supervision of a doctor who has experience in the management of patients with blood and/or kidney disorders.
Renal function, as measured by median eGFR, increased during Soliris therapy.
In patients with aHUS treated with Soliris, antibodies to Soliris were detected in 3/100(3%) by the ECL bridging format assay.
Thrombotic microangiopathy(TMA) complications have been observed as early as 4 weeks andup to 127 weeks following discontinuation of Soliris treatment in some patients.
Soliris is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Through data cut-off(October 12, 2012),with median duration of Soliris therapy of 44 weeks range: 1dose to 88 weeks.
All patients received Soliris and the study measured the number of red blood cell transfusions needed during the 12 weeks of treatment.
Through data cut-off(September 4, 2012),with median duration of Soliris therapy of 50 weeks range: 13 weeks to 86 weeks.
Antibodies to Soliris were detected in 2% of patients with PNH using an ELISA assay and 3% of patients with aHUS using the ECL bridging format assay.
In aHUS clinical studies, 61 patients(21 paediatric patients)discontinued Soliris treatment with a median follow-up period of 24 weeks.
Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks.
All aHUS patients treated with Soliris when administered as recommended demonstrated rapid and sustained reduction in terminal complement activity.
Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria PNH.
In aHUS Study C08-002A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Soliris treatment is recommended to continue for the patient's lifetime, unless the discontinuation of Soliris is clinically indicated see section 4.4.
At least two weeks before starting Soliris treatment, patients must be vaccinated against meningitis caused by the bacterium Neisseria meningitidis and revaccinated according to current guidelines.
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.
Soliris was studied in one main study involving 87 adults with PNH who had had at least four blood transfusions for anaemia in the previous year.
Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological and/or renal disorders.