Country: Israel
Language: English
Source: Ministry of Health
ECULIZUMAB
ALEXION PHARMA ISRAEL LTD
L04AA25
CONCENTRATE FOR SOLUTION FOR INFUSION
ECULIZUMAB 10 MG/ML
I.V
Required
ALEXION PHARMA GMBH, SWITZERLAND
ECULIZUMAB
ECULIZUMAB
Soliris is indicated for the treatment of patients with: - 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. Eculizumab has not been studied in clinical trials in patients with PNH below 11 years of age.- Atypical haemolytic uremic syndrome (aHUS).Soliris is indicated in adults for the treatment of: - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive.-Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease who have received prior therapy.
2015-07-31
aHUS Patient/Parent information brochure This document was last approved in March 2021 by the Israeli Ministry of Health (MOH) 1 For further information, please refer to the prescribing information as approved by the Israeli MOH TH) GLOSSARY OF TERMS Atypical hemolytic uremic syndrome (aHUS) A rare disorder caused by chronic and excessive activation of the complement system, a part of your normal immune system. The overactive complement system damages small blood vessels and causes the formation of blood clots throughout the body, a process which is called thrombotic microangiopathy (TMA). TMA can damage many organs including the brain, kidneys and heart. Blood clots Blood can form clots to stop bleeding, but in aHUS the blood forms clots very easily causing blockage of blood vessels and damage to organs. Haemolysis The abnormal destruction of red blood cells, which can cause varied signs and symptoms in aHUS. Chronic haemolysis The destruction of red blood cells (haemolysis) over a long period of time (chronic). Complement system (also known as the complement cascade or just complement) Part of your immune system that normally destroys bacteria and other foreign cells. In aHUS is chronically and excessively activated, which causes damage to your own tissues, by the destruction of small blood vessels and the formation of blood clots which damages the organs including the brain, kidneys, heart, and other organs. Gonococcal infection Infection sexually transmitted and caused by the bacterium Neisseria gonorrhoeae (also named gonorrhea). Can disseminate and cause widespread blood infection (sepsis). Kidney impairment or failure A condition in which the kidneys stop working and are unable to remove waste products or to be able to regulate the amount of water and essential substances in the body. Meningococcal infection An infection caused by the bacteria Neisseria meningitidis (also named meningococcus). This can cause meningitis or widespread blood infection (sepsis). Platelets Platelets are blood cells that can sti Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SOLIRIS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Eculizumab is a humanised monoclonal (IgG 2/4 κ ) 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 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colorless, pH 7.0 solution. PATIENT SAFETY INFORMATION CARD The marketing of Soliris is subject to a risk management plan (RMP) including a ‘Patient safety information card’. The ‘Patient safety information card’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Soliris is indicated for the treatment of patients with: - 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 5.1). Eculizumab has not been studied in clinical trials in patients with PNH below 11 years of age. - Atypical haemolytic uremic syndrome (aHUS) (see section 5.1). Soliris is indicated in adults for the treatment of: - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). - Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease who have received prior therapy (see section 5.1). 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of pat Read the complete document