Dried Factor VIII Fraction, Type 8Y

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FACTOR VIII, HUMAN

Available from:

Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom

ATC code:

B02BD06

INN (International Name):

FACTOR VIII, HUMAN 25 IU/ml

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

FACTOR VIII, HUMAN 25 IU/ml

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Suspended

Authorization date:

2006-03-24

Patient Information leaflet

B. PACKAGE LEAFLET
PATIENT INFORMATION LEAFLET
DRIED FACTOR VIII FRACTION, TYPE 8Y
Human Factor VIII and von Willebrand Factor (VWF)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
-Keep this leaflet. You may need to read it again.
-If you have any further questions, please ask your doctor.
-This medicine has been prescribed for you personally. Do not pass it
on to others. It may
harm them, even if their symptoms are the same as yours.
-If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
-Is this leaflet hard to see or read? Phone [phone].
IN THIS LEAFLET:
1.
What Dried Factor VIII Fraction (8Y) is and what it is used for
2.
Before you use 8Y
3
.How to use 8Y
4
.Possible side effects
5
.How to store 8Y
6.
Further Information
1. WHAT DRIED FACTOR VIII FRACTION (8Y) IS AND WHAT IT IS USED FOR
Dried Factor VIII fraction (8Y) is a concentrate of Factor VIII and
von Willebrand Factor (VWF)
prepared from blood plasma from screened donors and then heat-treated.
8Y is given by injection into a vein (intravenously) and is used to
prevent and treat bleeding in
patients with haemophilia A (an inherited shortage of Factor VIII in
the blood) or von Willebrand
disease (VWD). Your doctor will explain further why this medicine has
been given to you.
SUMMARY OF CONTENTS
VIAL SIZE OF 8Y
FACTOR VIII POTENCY
2
VWF POTENCY
3
250 IU
1
250 IU/Vial
500 IU/ Vial
500 IU
1
500 IU/Vial
1000 IU/ Vial
1 After reconstitution with appropriate amount of Sterile Water for
Injections (see Dissolving your
medicine before use)
2Potency complies with Ph.Eur. for Human Coagulation Factor VIII
3 Potency complies with Ph.Eur. for Human Coagulation Factor VIII for
preparations intended for the
treatment of von Willebrand’s disease
2. BEFORE YOU USE 8Y
YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU ARE:
•
ALLERGIC
(hypersensitive) to Factor VIII or von Willebrand Factor (VWF) or to
any of the
other ingredients in the product (See Section 6 ‘What

Summary of Product characteristics

_ _
_Page 1 of 12 _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_Page 2 of 12 _
SUMMARY OF PRODUCT CHARACTERISTICS
DRIED FACTOR VIII FRACTION, TYPE 8Y
®
Human Factor VIII and von Willebrand Factor (VWF)
1.
NAME OF THE MEDICINAL PRODUCT
Dried Factor VIII Fraction, Type 8Y
®
, 25 IU/mL powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dried Factor VIII Fraction, Type 8Y
®
, is presented as a powder for injection containing
nominally 250 IU or 500 IU of FVIII per vial.
Dried
Factor
VIII
Fraction,
Type
8Y
contains
approximately
25
IU/mL
human
coagulation factor VIII per mL (measured by activity assay) and human
von Willebrand
Factor (measured by VWF:RCo) at a potency of approximately 50 IU/mL.
The FVIII potency is determined using the European Pharmacopoeia
chromogenic
assay. The specific activity of FVIII in 8Y
®
is not less than 2 IU/mg protein.
Product from the plasma of human donors.
The
VWF
potency
(IU)
is
measured
according
to
Ristocetin
Cofactor
activity
(VWF:RCo), and ELISA antigen method, compared to an in-house standard
calibrated
against the International Standard for von Willebrand Factor
concentrate (WHO). The
ratio of FVIII to VWF antigen is approximately 1 IU:3 IU. The specific
activity of
VWF:RCo in 8Y
®
is not less than 2 IU/mg protein.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital
factor VIII deficiency).
Prevention and treatment of haemorrhage or surgical bleeding in von
Willebrand
disease (VWD), when desmopressin (DDAVP) treatment alone is
ineffective or contra-
indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Page 3 of 12 _
POSOLOGY
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia and other haemostatic disorders.
_HAEMOPHILIA A _
The dosage and duration of the substitution therapy depend on the
severity of the factor
VIII d