ELOCTATE efmoroctocog alfa (rhu) 1500 IU powder for injection vial and diluent pre-filled syringe
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
15-08-2017
Summary of Product characteristics
(SPC)
04-03-2022
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
efmoroctocog alfa, Quantity: 1500 IU
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
efmoroctocog alfa
Pharmaceutical form:
Drug delivery system
Composition:
Excipient Ingredients:
Administration route:
Intravenous
Units in package:
1s (vial + diluent)
Prescription type:
exempt from scheduling - Appendix A; prescription medicine
Therapeutic indications:
ELOCTATE is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia A (congenital factor VIII deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis). ELOCTATE does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.
Product summary:
Visual Identification: ; Container Type: Multiple containers; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-06-27
Patient Information leaflet
ELOCTATE
®
1
ELOCTATE
®
_Efmoroctocog alfa (recombinant coagulation factor VIII Fc fusion
protein) 250, 500, 750, 1000, 1500, _
_2000, 3000 IU/vial _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ELOCTATE.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet was last updated on the
date at the end of this leaflet.
SPEAK TO YOUR DOCTOR OR YOUR
HAEMOPHILIA TREATMENT CENTRE TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THIS MEDICINE.
You can also download the most
up to date leaflet from
www.medicines.org.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using ELOCTATE
against the benefits they expect it
will have for you.
If you have any concerns about using
this medicine, ask your doctor.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ELOCTATE IS
USED FOR
ELOCTATE is used for the
management of haemophilia A
(congenital factor VIII deficiency).
ELOCTATE is used to:
control and prevent bleeding
episodes
routinely prevent and reduce the
frequency of bleeding episodes
reduce bleeding before, during,
and after surgery.
Eloctate does not contain von
Willebrand factor and therefore is not
suitable for use in Von Willebrand’s
disease.
People with haemophilia A lack
sufficient factor VIII to control
bleeding. ELOCTATE works by
replacing factor VIII to enable blood
to clot.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
DO NOT GIVE THIS MEDICINE TO ANYONE
ELSE.
It may harm them, even if their
symptoms are the same as yours.
BEFORE YOU USE
ELOCTATE
_WHEN YOU MUST NOT USE IT _
DO NOT USE ELOCTATE IF YOU
HAVE AN ALLERGY TO:
ELOCTATE or other factor VIII
replacement factors
any of the ingredients listed at the
end of this leafl
Read the complete document
Summary of Product characteristics
elo-ccdsv12-piv10-03mar22
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION – ELOCTATE
(EFMOROCTOCOG ALFA) (RHU) POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Efmoroctocog alfa
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains nominally 250, 500, 750, 1000, 1500,
2000, or 3000 International
Units (IU) of efmoroctocog alfa.
Each pre-filled syringe contains 3 mL of solvent.
Efmoroctocog alfa is produced by recombinant DNA technology in a human
embryonic kidney
(HEK) cell line, which has been extensively characterised. The HEK
cell line expresses
efmoroctocog alfa into a defined cell culture medium that does not
contain any proteins derived
from animal or human sources. The purification process utilises a
series of chromatography and
multiple viral clearance steps. The viral clearance steps include
affinity chromatography, 15nm
virus-retaining nano-filtration step, and detergent viral
inactivation. No human or animal derived
additives are used in the purification and formulation processes.
For the full list of excipients, see Section 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
ELOCTATE is formulated as a sterile, preservative-free, non-pyrogenic,
lyophilised, white to off-
white powder to cake, for intravenous (IV) administration in a
single-use vial.
The liquid diluent (sterile water for injections) is in a pre-filled
syringe.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELOCTATE is a long-acting antihaemophilic factor (recombinant)
indicated in adults and
children with haemophilia A (congenital factor VIII deficiency) for:
•
Control and prevention of bleeding episodes.
elo-ccdsv12-piv10-03mar22
Page 2 of 32
•
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes.
•
Perioperative management (surgical prophylaxis).
ELOCTATE does not contain von Willebrand factor, and therefore is not
indicated in patients
with von Willebrand’s disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
For Intravenous Us
Read the complete document
