Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
RAVULIZUMAB
ALEXION PHARMA ISRAEL LTD
L04AA43
CONCENTRATE FOR SOLUTION FOR INFUSION
RAVULIZUMAB 100 MG/ML
I.V
Required
ALEXION PHARMA INTERNATIONAL OPERATIONS LIMITED, IRELAND.
RAVULIZUMAB
Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (PNH): * In patients with haemolysis with clinical symptom(s) indicative of high disease activity. * In patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome aHUS who are complement inhibitor treatment naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab. Ultomiris is indicated in the treatment of adult patients with generalized myasthenia gravis (gMG) who are antiacetylcholine receptor (AChR) antibody-positive.
2023-05-30
Page 1 of 31 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ultomiris 10 mg/ml Ultomiris 100 mg/ml Concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ultomiris is a formulation of ravulizumab, produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology. Ultomiris 300 mg/3 mL concentrate for solution for infusion Each vial of 3 mL contains 300 mg of ravulizumab (100 mg/mL). After dilution, the final concentration of the solution to be infused is 50 mg/mL. _Excipient(s) with known effect: _ Sodium (4.6 mg per 3 mL vial) Ultomiris 1,100 mg/11 mL concentrate for solution for infusion Each vial of 11 mL contains 1,100 mg of ravulizumab (100 mg/mL). After dilution, the final concentration of the solution to be infused is 50 mg/mL. _Excipient(s) with known effect: _ Sodium (16.8 mg per 11 mL vial) Ultomiris 300 mg/30 mL concentrate for solution for infusion Each vial of 30 mL contains 300 mg of ravulizumab (10 mg/mL). After dilution, the final concentration of the solution to be infused is 5 mg/mL. _Excipient(s) with known effect: _ Sodium (115 mg per 30 mL vial) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Ultomiris 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion Translucent, clear to yellowish colour, pH 7.4 solution. Ultomiris 300 mg/30 mL concentrate for solution for infusion Clear to translucent, slight whitish colour, pH 7.0 solution. Page 2 of 31 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Paroxysmal nocturnal haemoglobinuria (PNH) _ Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with PNH: - in patients with haemolysis with clinical symptom(s) indicative of high disease activity - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months _Atypical haemolytic uremic syndrome (aHUS) _ Ultomiris is indicated in Đọc toàn bộ tài liệu