Elocta 250unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Efmoroctocog alfa

Available from:

Swedish Orphan Biovitrum Ltd

INN (International Name):

Efmoroctocog alfa

Dosage:

250unit

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 7350031440720

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELOCTA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 750 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
efmoroctocog alfa (recombinant coagulation factor VIII)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 ELOCTA is and what it is used for
2.
What you need to know before you use ELOCTA
3.
How to use ELOCTA
4.
Possible side effects
5.
How to store ELOCTA
6.
Contents of the pack and other information
7.
Instructions for preparation and administration
1.
WHAT ELOCTA IS AND WHAT IT IS USED FOR
ELOCTA contains the active substance efmoroctocog alfa, a recombinant
coagulation factor VIII,
Fc fusion protein. Factor VIII is a protein produced naturally in the
body and is necessary for the
blood to form clots and stop bleeding.
ELOCTA is a medicine used for the treatment and prevention of bleeding
in all age groups of patients
with haemophilia A (inherited bleeding disorder caused by factor VIII
deficie

Summary of Product characteristics

OBJECT 1
ELOCTA POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 05-Dec-2017 | Swedish
Orphan Biovitrum Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
ELOCTA 250 IU powder and solvent for solution for injection
ELOCTA 500 IU powder and solvent for solution for injection
ELOCTA 750 IU powder and solvent for solution for injection
ELOCTA 1000 IU powder and solvent for solution for injection
ELOCTA 1500 IU powder and solvent for solution for injection
ELOCTA 2000 IU powder and solvent for solution for injection
ELOCTA 3000 IU powder and solvent for solution for injection
2. Qualitative and quantitative composition
ELOCTA 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 83 IU efmoroctocog alfa.
ELOCTA 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 167 IU efmoroctocog alfa.
ELOCTA 750 IU powder and solvent for solution for injection
Each vial contains nominally 750 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 250 IU efmoroctocog alfa.
ELOCTA 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 333 IU efmoroctocog alfa.
ELOCTA 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 500 IU efmoroctocog alfa.
ELOCTA 2000 IU powder and solvent for sol