Octanate, 100 IU/ml Powder and solvent for solution for injection

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

FACTOR VIII, HUMAN

Sẵn có từ:

Octapharma (IP) Limited

Mã ATC:

B02BD02

INN (Tên quốc tế):

FACTOR VIII, HUMAN

Dạng dược phẩm:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Thành phần:

FACTOR VIII, HUMAN 100 IU/ml

Loại thuốc theo toa:

POM

Khu trị liệu:

ANTIHEMORRHAGICS

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2010-07-06

Tờ rơi thông tin

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTANATE 50 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN COAGULATION FACTOR VIII
OCTANATE 100 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN COAGULATION FACTOR VIII
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, 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 Octanate is and what it is used for
2. What do you need to know before you use Octanate
3. How to use Octanate
4. Possible side effects
5. How to store Octanate
6. Contents of the pack and other information
1.
WHAT OCTANATE IS AND WHAT IT IS USED FOR
Octanate belongs to a group of medicines called clotting factors and
contains human
blood coagulation factor VIII. This is a special protein involved in
blood clotting.
Octanate is used to treat and prevent bleeding in patients with
haemophilia A. This is a
condition in which bleeding can go on for longer than expected. It is
due to an
hereditary lack of coagulation factor VIII in the blood.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU USE OCTANATE
It is strongly recommended that every time you receive a dose of
Octanate the name
and batch number of the product are recorded in order to maintain a
record of the
batches used.
Your doctor may recommend that you consider vaccination against
hepatitis A and B if
you regularly or repeatedly receive human-derived Factor VIII
prodcuts.
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DO NOT USE OCTANATE
if you are allergic to human blood coagulation factor VIII or to any
of the other
ingr

Đặc tính sản phẩm

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Octanate 100 IU/ml
Powder and solvent for solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octanate 100 IU/ml contains nominally 1000 IU human coagulation factor
VIII per vial.
The product contains approximately 100 IU* per ml human coagulation
factor VIII when
reconstituted with 10 ml of solvent.
Produced from the plasma of human donors.
The product contains approximately ≤ 60 IU per ml von Willebrand
factor (VWF:RCo).
Excipient with known effect:
Sodium up to 1.75 mmol (40 mg) per dose
Sodium concentration after reconstitution: 125 – 175 mmol/l
For the full list of excipients, see section 6.1.
* The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The
mean specific activity of Octanate is ≥ 100 IU/mg protein.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white or pale yellow, also appearing as a friable solid.
The solvent is a clear, colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency)
This preparation does not contain von Willebrand factor in
pharmacologically effective
quantities and is therefore not indicated in von Willebrand’s
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a physician experienced
in the treatment of
haemophilia.
POSOLOGY
The dose 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 World Health Organisation (WHO)
international standard for
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factor VIII products. Factor VIII activity in plasma is expressed
either as a percentage
(relative to normal human plasma) or in International