Haemate P 500

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

human blood coagulation factor VIII, human Von Willebrand Factor (VWF:RCo)

から入手可能:

CSL Behring GmbH

INN（国際名）:

human blood coagulation factor VIII, human Von Willebrand Factor (VWF:RCo)

投薬量:

500IU+1200IU

医薬品形態:

powder and solvent for solution for injection/ infusion

処方タイプ:

Prescription

情報リーフレット

WHAT IS IN THIS LEAFLET:
1. What Haemate is and what it is used for
2. What you need to know before you use Haemate
3. How to use Haemate
4. Possible side effects
5. How to store Haemate
6. Contents of the pack and other information
1. WHAT HAEMATE IS AND WHAT IT IS USED FOR
WHAT IS HAEMATE?
Haemate is presented as powder and solvent. The made up solution is to
be given
by injection or infusion into a vein.
Haemate 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.
WHAT IS HAEMATE USED FOR?
Von Willebrand disease (VWD)
Haemate 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 contraindicated.
Haemophilia A (congenital factor VIII deficiency)
Haemate 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HAEMATE
The following sections contain information that your doctor should
consider before
you are given Haemate.
DO NOT USE HAEMATE:
• if you are hypersensitive (allergic) to human von Willebrand
Factor or human
coagulation factor VIII or any of the other ingredients of Haemate
(see section 6.).
PLEASE INFORM YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY MEDICINE OR FOOD.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Haemate:
• IN CASE OF ALLERGIC OR ANAPHYLACTIC-TYPE REACTIONS (a serious
allergic reaction
that causes severe difficulty in breathing or dizziness). Allergic
hypersensitivity
reactions are possible. Your doctor should inform you OF THE EARLY
SIGNS OF
HYPERSENSITIVITY REACTIONS, such as hives, generalised skin rash,
tightness of
the chest, wheezing, fall in blood pressure and anaphylaxis (a serious
allergic
reaction that causes severe difficulty in br

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
HAEMA TE@P
_250/500/1000_
This SPC is an altered (re-named)
version of Haemate CCDS.
It is based on Haemate CCDS (Rev.:
07-JAN-2014
_I_
adaptation to FVIII
_Core-SPC/QRD)._
CSLB.:h,ing
Page 1 of18
1.
NAME OF THE MEDICINAL PRODUCT
Haemate~ P 250/500/1000
Powder
and solvent
for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial
contains
nominally:
250/50011000 IU human coagulation factor VIll
(FVIII).
600/1200/2400
ill
human von Willebrand factor (VWF).
After reconstitution
with 5110ml Haemate P 250/500 contains
50 IU/ml
ofFVIll
and 120
ill/ml
ofVWF.
After reconstitution with 15 ml Haemate P 1000 contains 66.6 Il.I/ml
of
FVIlI
and 160 IU/ml
ofVWF.
The Fvm potency (lU) is determined using the European Pharmacopoeia
chromogenic
assay.
The specific FVIll
activity of Haemate is approximately 2 - 6 IU ofFVIlllmg
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 is approximately
5 - 17 IU ofVWF:RCo/mg
protein.
Haemate is produced from the plasma of human donors.
Excipient
with known effect:
Sodium:
250/500 IU -
approximately
113 mmolll
(2.6 mg/ml)
1000 IU -
approximately
150 mmolll
(3.5 mg/ml)
For the full
list of excipients,
see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent
for solution for injection or infusion.
White powder
and clear,
colourless solvent
for solution for injection/infusion.
CSLBehring
Page2of18
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_Von Willebrand Disease (VWD)_
Prophylaxis and treatment
ofhaemorrhage
or surgical
bleeding,
when desmopressin
(DDAVP) treatment
alone is ineffective or contra-indicated.
_HaemophiliaA_
_(congenitalfactor_
_VIII deficiency)_
Prophylaxis and treatment
of bleeding in patients with haemophilia
A.
This product
may be used in the management
of acquired factor
VllI deficiency and for
treatment
of patients with antibodies against