Soliris 300mg30ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eculizumab

Available from:

Alexion Pharma UK Ltd

ATC code:

L04AA25

INN (International Name):

Eculizumab

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010300; GTIN: 5391527741008

Patient Information leaflet

1
Package leaflet: Information for the user
Soliris 300 mg concentrate for solution for infusion
Eculizumab
Read all of this leaflet carefully before you start using this
medicine because it contains
important information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Soliris is and what it is used for
2.
What you need to know before you use Soliris
3.
How to use Soliris
4.
Possible side effects
5.
How to store Soliris
6.
Contents of the pack and other information
1. What Soliris is and what it is used for
What is Soliris
Soliris contains the active substance eculizumab and it belongs to a
class of medicines called
monoclonal antibodies. Eculizumab binds to and inhibits a specific
protein in the body that causes
inflammation and so prevents your body’s systems from attacking and
destroying vulnerable blood
cells.
What is Soliris used for
Paroxysmal Nocturnal Haemoglobinuria
Soliris is used to treat adults and children patients with a certain
type of disease affecting the blood
system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients
with PNH, their red blood
cells can be destroyed which can lead to low blood counts (anaemia),
tiredness, difficulty in
functioning, pain, dark urine, shortness of breath, and blood clots.
Eculizumab can block the body’s
inflammatory response, and its ability to attack and destroy its own
vulnerable PNH blood cells.
Atypical Haemolytic Uremic Syndrome
Soliris is also used to treat adults and children patients with a
certain type of disease affecting the
blood system and kidney called atypical Haemolytic Uremic Syndrome
(aHUS). In patients with
aHU

Summary of Product characteristics

OBJECT 1
SOLIRIS
Summary of Product Characteristics Updated 02-Jan-2018 | Alexion
Pharma UK Ltd
1. Name of the medicinal product
Soliris 300 mg concentrate for solution for infusion
2. Qualitative and quantitative composition
Eculizumab is a humanised monoclonal (IgG
2/4κ
) 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.
4. Clinical particulars
4.1 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 5.1).
- 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).
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 patients with haematological, renal
or neuromuscular disorders.
Posology
Adult Patients:
In Paroxysmal Nocturnal Haemoglobinuria (PNH):
The PNH dosing regimen for adult patients (≥18 years of age)
consists of a 4-week initial phase followed
by a maintenance phase:
• Initial phase: 600 mg of Soliris administered via a 25 – 45
minute intravenous infusion every week for
the first 4 weeks.
• Maintenance phase: 900 mg of Soliris administered via a 25 – 45
minute intravenous infusion for the
fifth week, followed by 900 mg of Soliris administered via a 25 – 45
minute