Octanate LV 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:

2014-10-17

Tờ rơi thông tin

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTANATE LV 100IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN COAGULATION FACTOR VIII
OCTANATE LV 200 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 LV is and what it is used for
2. What do you need to know before you use Octanate LV
3. How to use Octanate LV
4. Possible side effects
5. How to store Octanate LV
6. Contents of the pack and other information
1.
WHAT OCTANATE LV IS AND WHAT IT IS USED FOR
Octanate LV 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 LV 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 LV
It is strongly recommended that every time you receive a dose of
Octanate LV 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.
DO NOT USE OCTANATE LV
if you are allergic to human blood coagulation factor VIII or to any
of the other ingredients of
this

Đặc tính sản phẩm

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SUMMARY OF PRODUCT CHARACTERISTICS 
1 
NAME OF THE MEDICINAL PRODUCT 
OCTANATE LV 100 IU/ML 
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Octanate LV 100 IU/ml contains nominally 500 IU human coagulation factor VIII per vial. 
The  product  contains  approximately  100 IU*  per  ml  human  coagulation  factor  VIII  when 
reconstituted with 5 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: 250 – 350 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 LV 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 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 th