Soliris Concentrate for Solution for Infusion 300mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Eculizumab

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

L04AA25

Dosage:

300 mg / vial

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Eculizumab 300 mg / vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Alexion Pharma International Operations Limited (AAMF)

Authorization status:

ACTIVE

Authorization date:

2012-09-12

Patient Information leaflet

 
1 

1. 
NAME OF THE MEDICINAL PRODUCT 

Soliris 300 mg concentrate for solution for infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

2.1  GENERAL DESCRIPTION 

Eculizumab is a humanised monoclonal IgG
2/4κ
 antibody produced in NS0 cell line by recombinant 
DNA technology. 

2.2  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial of 30 ml contains 300 mg  of eculizumab (10 mg/ml). 

After dilution, the final concentration of the solution to be infused
is 5mg/ml. 

Excipients: Sodium (5.00 mmol per dose (1 vial)) 

For a 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 
INDICATION 

Soliris (eculizumab) is indicated for the treatment of patients with
paroxysmal nocturnal 
haemoglobinuria (PNH). 

Evidence of clinical benefit of Soliris in the treatment of patients
with PNH is limited to patients with 
history of transfusions. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

To reduce the risk of meningococcal infection (_Neisseria
meningitidis_), all patients must be vaccinated 
at least 2 weeks prior to receiving Soliris and must be re-vaccinated
according to current medical 
guidelines for vaccination use (see section 4.4). 
Soliris should be administered by a healthcare professional and under
the supervision of a physician 
experienced in the management of patients with haematological
disorders. 
Posology 
The dosing regimen consists of a 5-week initial phase followed by a
maintenance phase: 
  Initial phase:  600 mg of Soliris via a 25 - 45 minute
intravenous infusion every week for the 
first 4 weeks, followed by 900 mg of Soliris for the fifth week of
the initial phase.   

2 

  Maintenance phase: 900 mg of Soliris administered via a 25
- 45 minute intravenous infusion 
every 14 ± 2 days (see Section 5.1).�

Summary of Product characteristics

SOLIRIS
®
(ECULIZUMAB)
1.
NAME OF THE MEDICINAL PRODUCT
SOLIRIS 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Eculizumab is a humanised monoclonal (IgG
2/4κ
) antibody produced in NS0 cell line by
recombinant DNA technology.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 (5mmol per vial)
For a 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
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).
•
Atypical Haemolytic Uremic Syndrome (aHUS) (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 and/or renal
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 intravenous infusion every 14 ± 2 days (see section 5.1).
_IN ATYPICAL HAEMOLYTIC UREMIC SYNDROME (AHUS): _
The aHUS dosing regimen for adult patients (≥ 18 years of age)
consists of a 4-w