Haemate P 1000IU Powder and solvent for solution for injection or infusion

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

Human coagulation factor VIII; Von Willebrand Factor

Dostupné s:

DKSH MALAYSIA SDN. BHD.

INN (Mezinárodní Name):

Human coagulation factor VIII; Von Willebrand Factor

Jednotky v balení:

1 Vials

Výrobce:

CSL Behring GmbH

Informace pro uživatele

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HAEMATE P
_®_ POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION OR INFUSION
Human Coagulation Factor VIII/ Human Von Willebrand Factor (250IU
FVIII / 600IU VWF, 500IU FVIII / 1200IU VWF, 1000IU
FVIII / 2400IU VWF)
Page 1
WHAT IS IN THIS LEAFLET
1. What Haemate P
®
is used for
2. How Haemate P
®
works
3. Before you use Haemate P
®
4. How to use Haemate P
®
5. While you are using Haemate P
®
6. Side effects
7. Storage and Disposal of Haemate P
®
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT HAEMATE P
®
IS USED FOR
Haemate P
®
is supplied as powder and
solvent. The made up solution is to be
given by injection or infusion into a vein.
Haemate P
®
is made from human plasma
(this is the liquid part of the blood) and it
contains human von Willebrand factor
and human coagulation factor VIII.
As Haemate P
®
contains both FVIII and
VWF, it is important to know which
factor you most need. If you have
haemophilia A your doctor will prescribe
you Haemate P
®
with the number of units
of FVIII specified. If you have VWD
your doctor will prescribe you Haemate
P
®
with the number of units of VWF
specified.
HOW HAEMATE P
® WORKS
Von Willebrand disease (VWD)
Haemate P
®
is used for the prevention
and treatment of bleedings or surgical
bleeding caused by the lack of von
Willebrand factor, when desmopressin
(DDAVP) treatment alone is ineffective
or contra-indicated.
Haemophilia A (congenital factor VIII
deficiency)
Haemate P
®
is used to prevent or to stop
bleedings caused by the lack of factor
VIII in the blood.
It may also be used in the management of
acquired factor VIII deficiency and for
treatment of patients with antibodies
against factor VIII.
BEFORE YOU USE HAEMATE P
®
_- When you must not use it _
Tell your doctor if you:
•
are hypersensitive (allergic) to
human von Willebrand Factor or
human coagulation factor VIII or any
of the other ingredients of Haemate
P
®
•
are allergic to any medicine or food.
_-

Charakteristika produktu

CSL BEHRING CCDS
HUMAN COAGULATION FVIII + HUMAN VWF, HAEMATE
®
VERSION 11.0 REVISION DATE 30-AUG-2019
Clean_GRDC_67ad03
Page 2 of 17
1.
NAME OF THE MEDICINAL PRODUCT
Haemate P
_ _
Powder and solvent for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial
_Haemate P 250IU FVIII/ 600IU VWF _
contains nominally:
250 IU human coagulation factor VIII (FVIII).
600 IU human von Willebrand factor (VWF).
After reconstitution with 5ml the solution contains 50 IU/ml of FVIII
and 120 IU/ml of
VWF.
One vial
_Haemate_
_ _
_P_
_500 IU FVIII /1200 IU VWF _
contains nominally:
_ _
500IU human coagulation factor VIII (FVIII).
1200 IU human von Willebrand factor (VWF).
After reconstitution with 10 ml the solution contains 50 IU/ml of
FVIII and 120 IU/ml of
VWF.
One vial
_Haemate_
_ _
_P 1000 IU FVIII /2400 IU VWF _
contains nominally:
_ _
1000IU human coagulation factor VIII (FVIII).
2400 IU human von Willebrand factor (VWF).
After reconstitution with 15 ml the solution contains 66.6 IU/ml of
FVIII and 160 IU/ml of
VWF.
The FVIII potency (IU) is determined using the European Pharmacopoeia
chromogenic
assay. The specific FVIII activity of
_Haemate P_
is approximately 2 - 6 IU of FVIII/mg
protein
The VWF potency (IU) is measured according to ristocetin cofactor
activity (VWF:RCo)
compared to the International Standard for von Willebrand factor
concentrate (WHO)The
specific VWF activity of
_ Haemate P_
is approximately 5 - 17 IU of VWF:RCo/mg protein.
_Haemate P_
is produced from the plasma of human donors.
Excipient with known effect:
Sodium:
_Haemate P 250 IU FVIII/600 IU VWF and Haemate P 500 IU FVIII / 1200
IU VWF _
– approximately 113 mmol/l (2.6 mg/ml)
_Haemate_
_ _
_P_
_1000 IU FVIII /2400 IU VWF_
– approximately 150 mmol/l (3.5 mg/ml)
_ _
For the full list of excipients, see section 6.1
CSL BEHRING CCDS
HUMAN COAGULATION FVIII + HUMAN VWF, HAEMATE
®
VERSION 11.0 REVISION DATE 30-AUG-2019
Clean_GRDC_67ad03
Page 3 of 17
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injectio