Fanhdi 1000 IU powder and solvent for solution for injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Human coagulation factor viii

可用日期:

Instituto Grifols S.A.

ATC代码:

B02BD; B02BD02

INN（国际名称）:

Human coagulation factor viii

剂量:

1000 international unit(s)

药物剂型:

Powder and solvent for solution for injection

处方类型:

Product subject to prescription which may not be renewed (A)

治疗领域:

Blood coagulation factors; coagulation factor VIII

授权状态:

Not marketed

授权日期:

2000-07-07

资料单张

Fanhdi\2016 PRAC Fanhdi\IE Fanhdi PIL_clean.doc
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FANHDI 250, 500 AND 1000 IU, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Human coagulation factor VIII, Ph.Eur.
PLEASE READ 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 any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fanhdi is and what it is used for
2.
What you need to know before you use Fanhdi
3.
How to use Fanhdi
4.
Possible side effects
5.
How to store Fanhdi
6.
Contents of the pack and other information
1.
WHAT FANHDI IS AND WHAT IT IS USED FOR
Fanhdi is supplied as a powder for solution for injection containing
250, 500 or 1000 IU of human
coagulation factor VIII per vial. (Note IU stands for international
unit, a standard measure of activity).
Once reconstituted with the appropriate amount of solvent (water for
injections), each vial contains 25,
50 or 100 IU of FVIII/ml.
Fanhdi is one of the group of medicines called clotting factors.
Fanhdi is used for the treatment and prevention of bleeding in
patients with haemophilia A (congenital
factor VIII deficiency).
This product may be used in the management of acquired factor VIII
deficiency.
No data is available to recommend the use of Fanhdi in von Willebrand
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FANHDI
DO NOT USE FANHDI

If you are allergic to human coagulation factor VIII or to any of the
other ingredients of this
medicine (listed in section 6).

If you have not been fully trained how to inject yourself by your
doctor or haemophilia nurse.
If you want more detailed infor

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fanhdi 1000 IU powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human coagulation factor VIII.
Fanhdi is presented as a lyophilised powder for solution for injection
containing nominally 1000 IU human coagulation
FVIII per vial.
The product contains approximately 100 IU/ml of human coagulation
factor VIII when reconstituted with 10 ml of
water for injections.
The FVIII:C potency (IU) is determined using the European
Pharmacopoeia chromogenic assay. The specific activity
of Fanhdi is at least of 10 IU FVIII:C/mg protein.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Vial containing white or pale yellow powder and syringe with Water for
Injections (solvent).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fanhdi is indicated for the treatment and prophylaxis of bleeding in
patients with haemophilia A (congenital factor VIII
deficiency).
No data is available to recommend the use of Fanhdi in von Willebrand
disease.
This product may be used in the management of acquired factor VIII
deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of haemophilia.
_Posology_
The dosage and duration of the substitution therapy depend on the
severity of the factor VIII deficiency, on the location
and extent of the bleeding and on the patient’s clinical condition.
The number of units of factor VIII administered is expressed in
International
Units (IU),
which are related to the
current
WHO standard for factor VIII products.
Factor VIII activity in plasma is expressed either as a percentage
(relative to normal
human plasma) or in International
Units (relative to an International
Standard for factor VIII in
plasma).
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