Examples of using Soliris in English and their translations into German
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Medicine
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Colloquial
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Ecclesiastic
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
Most Recent Soliris Dose.
Using Soliris with other medicines.
Being carefully monitored by your doctor following any discontinuation of Soliris treatment.
In aHUS Study C08-003A/B, the median duration of Soliris therapy was approximately 114 weeks range: 26 to 129 weeks.
The card will also provide information to healthcare professionals that the patient is receiving Soliris treatment.
In aHUS Study C08-002A/B, the median duration of Soliris therapy was approximately100 weeks range: 2 weeks to 145 weeks.
Twenty of the 24 patients who required dialysis atbaseline were able to discontinue dialysis during Soliris treatment.
Despite Soliris re-initiation following discontinuation, progression to end stage renal disease occurred in one patient.
If you forget an appointment, please contact your doctor immediately for advice andsee section below“If you stop using Soliris”.
After 3 weeks of Soliris treatment, patients reported less fatigue and improved health- related quality of life.
In the study in children, six out of seven patients did not need any transfusion ofred blood cell and haemoglobin levels improved during treatment with Soliris.
After 3 weeks of Soliris treatment, patients reported less fatigue and improved health-related quality of life.
Thrombotic microangiopathy(TMA) complications have been observed as early as 4 weeks andup to 127 weeks following discontinuation of Soliris treatment in some patients.
Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections.
Soliris treatment is recommended to continue for the patient's lifetime, unless the discontinuation of Soliris is clinically indicated see section 4.4.
In the main study, 21(49%) of the 43 patients receiving Soliris had stable haemoglobin levels, and, on average, they did not need any transfusions of red blood cells.
Soliris therapy must not be initiated without prior vaccination against Neisseria meningitidis at least 2 weeks prior to initial administration.
In the main study in PNH, 49% of the adult patients receiving Soliris had stable haemoglobin levels(21 out of 43), and, on average, they did not need any transfusions of red blood cells.
Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningitis infection of the linings of the brain.
Additionally, all patients must be vaccinated against meningococcus at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweigh the risks of developing a meningococcal infection.
Soliris is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and inhibits the activation of terminal complement.
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 outweigh the risks of developing a meningococcal infection.
Treatment with Soliris consists of an intravenous infusion(drip into a vein) of 600 mg over 25 to 45 minutes once a week, followed by 900 mg in the fifth week.
Longer term treatment with Soliris(median 52 weeks ranging from 15 to 126 weeks) was associated with an increased rate of clinically meaningful improvements in adult patients with aHUS.
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.
Administration• Do not administer Soliris as an intravenous Push or Bolus Injection• Soliris should only be administered via intravenous infusion and must be diluted to a final concentration of 5 mg/ml prior to administration.
Maintenance phase: 1,200 mg of Soliris administered via a 25- 45 minute intravenous infusion for the fifth week, followed by 1,200 mg of Soliris administered via a 25- 45 minute intravenous infusion every 14± 2 days see section 5.1.
The company that makes Soliris will agree the details of a system in each Member State that will ensure that distribution of the medicine only occurs after checking that the patient has been vaccinated appropriately.
Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningitis, at least 2 weeks before beginning therapy, or that your current meningitis vaccination is up to date.
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.