SOLIRIS

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ECULIZUMAB

MAH:

ALEXION PHARMA ISRAEL LTD

ATC_code:

L04AA25

pharmaceutical_form:

CONCENTRATE FOR SOLUTION FOR INFUSION

composition:

ECULIZUMAB 10 MG/ML

administration_route:

I.V

prescription_type:

Required

manufactured_by:

ALEXION PHARMA GMBH, SWITZERLAND

therapeutic_group:

ECULIZUMAB

therapeutic_area:

ECULIZUMAB

therapeutic_indication:

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.

authorization_date:

2015-07-31

PIL

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

SPC

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