Dried Factor VIII Fraction type 8Y 500unit powder and solvent for solution for injection vials

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Factor VIII; von Willebrand factor

Boleh didapati daripada:

Bio Products Laboratory Ltd

Kod ATC:

B02BD06

INN (Nama Antarabangsa):

Factor VIII; von Willebrand factor

Dos:

500unit ; 1000unit

Borang farmaseutikal:

Powder and solvent for solution for injection

Laluan pentadbiran:

Intravenous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Never Valid To Prescribe As A VMP

Ringkasan produk:

BNF: 02110000; GTIN: 5019943000249

Risalah maklumat

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 +44 (0)20
8957 2200.
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.
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 _
_8Y contains’)_
SPECIAL CARE MUST BE TAKEN WITH 8Y IF YOU:
•
DEVELOP AN ALLERGIC REACTION _(see Section 4 _
_‘Possible side effects’ for a list of these)_ STOP
THE TREATMENT IMMEDIATELY AND TELL YOUR
DOCTOR.
•
ARE BLOOD GROUP A, B OR AB and need large
doses of the medicine. Your doctor will carry out
regular blood tests to check your red blood cells
because this medicine contains small amounts
of blood group antibodies which are present in
the plasma that the medici

Ciri produk

OBJECT 1
DRIED FACTOR VIII FRACTION, TYPE 8Y
Summary of Product Characteristics Updated 15-Jul-2013 | Bio Products
Laboratory Limited
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. The vials also contain at least 260 IU
or 520 IU von Willebrand Factor.
The product contains approximately 25 IU/mL human coagulation factor
VIII per mL (measured by
activity assay) and at least 26 IU/mL human von Willebrand Factor
(measured by VWF:RCo) when
reconstituted with 10 mL (250 IU) or 20 mL (500 IU) of Sterilised
Water for Injections, (Ph.Eur.).
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.
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
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 deficie