Haemate P 1,000unit powder and solvent for solution for injection vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Factor VIII; von Willebrand factor

可用日期:

CSL Behring UK Ltd

ATC代码:

B02BD06

INN（国际名称）:

Factor VIII; von Willebrand factor

剂量:

1000unit ; 2400unit

药物剂型:

Powder and solvent for solution for injection

给药途径:

Intravenous

类:

No Controlled Drug Status

处方类型:

Never Valid To Prescribe As A VMP

產品總結:

BNF: 02110000; GTIN: 5028360000152

资料单张

1
CSL BEHRING
PATIENT INFORMATION LEAFLET
HAEMATE
® P 1000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION
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 further questions, please ask your doctor or your
haemophilia nurse.
•
This medicine has been prescribed for you personally and you should
not pass it on
to others. It may harm them, even if their symptoms are the same as
yours.
•
If you get any side effects, please tell your doctor or haemophilia
nurse. This includes
any side effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Haemate P is and what it is used for
2.
What you need to know before you use Haemate P
3.
How to use Haemate P
4.
Possible side effects
5.
How to store Haemate P
6.
Contents of the pack and other information
1. WHAT HAEMATE P IS AND WHAT IT IS USED FOR
Haemate P is a product made from human plasma (this is the liquid part
of the blood). It
contains human von Willebrand factor and human coagulation factor
VIII.
It is used to prevent or stop the bleeding caused by a lack of factor
VIII (haemophilia A) or
von Willebrand factor (von Willebrand disease) in your blood. Both
these factors are needed
for the formation of blood clots which help bleeding to stop.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HAEMATE P
DO NOT USE HAEMATE P
•
If you are allergic to any of the ingredients. If you are unsure about
this, ask your doctor
(see section 6).
TAKE SPECIAL CARE WITH HAEMATE P
•
If you experience any signs of an allergic reaction to Haemate P (for
example a rash,
tight chest, wheezing or feeling dizzy), stop injecting the product
IMMEDIATELY
and
contact your doctor.
•
The formation of
INHIBITORS
(antibodies) is a known complication that can occur during
treatment with all factor VIII medicines. These inhibitors, especially
at high levels, stop
the treatment working properly and you or your child will be

产品特点

OBJECT 1
HAEMATE P 1000 IU
Summary of Product Characteristics Updated 04-Jan-2018 | CSL Behring
UK Limited
1. Name of the medicinal product
Haemate P 1000 IU Powder and solvent for solution for injection or
infusion
2. Qualitative and quantitative composition
One vial contains nominally 1000 IU human coagulation factor VIII
(FVIII) and 2400 IU human von
Willebrand Factor (VWF).
After reconstitution with 15 ml Water for Injections, Haemate P 1000
IU contains 66.6 IU/ml FVIII and
160 IU/ml VWF.
The FVIII (IU) potency is determined using the European Pharmacopoeia
chromogenic assay. The
specific FVIII activity of Haemate P is approximately 2 - 6 IU
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
VWF:RCo/mg protein.
Haemate P is produced from the plasma of human donors.
Excipient with known effect:
Sodium - approximately 150 mmol/l (3.5 mg/ml)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White powder and clear, colourless solvent for solution for injection
or infusion
4. Clinical particulars
4.1 Therapeutic indications
_VON WILLEBRAND DISEASE (VWD)_
Prophylaxis and treatment of haemorrhage or surgical bleeding, when
desmopressin (DDAVP) treatment
alone, is ineffective or contra-indicated.
_HAEMOPHILIA A (CONGENITAL FACTOR VIII DEFICIENCY)_
Prophylaxis and treatment of bleeding in patients with haemophilia A.
This product may be used in the management of acquired factor VIII
deficiency and for the treatment of
patients with antibodies against factor VIII (see section 4.4).
4.2 Posology and method of administration
Treatment of VWD and haemophilia A should be supervised by a physician
experienced in the treatment
of haemostatic disorders.
POSOLOGY
Von Willebrand Disease
Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by
0.02 IU/ml (2%).
Levels of VWF:RCo greater than 0.6