Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
{{id}} {{{paragraph}}}
Example: tourism industry
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Eculizumab is a humanised monoclonal (IgG2/4 ) antibody produced in NS0 cell line by recombinant DNA technology. One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml). After dilution, the final concentration of the solution to be infused is 5 mg/ml. Excipients with known effect: Sodium (5 mmol per vial) For the full list of excipients, see section 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colorless, pH solution. 4. CLINICAL PARTICULARS Therapeutic indications Soliris is indicated in adults and children for the treatment of: - Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section ).
of delaying Soliris therapy outweighs the risks of developing a meningococcal infection. Patients who ... official guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in Soliris-treated patients. Sepsis is …
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: