Octanate 50IU/ml powder and solvent for solution for injection (5ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FACTOR VIII, HUMAN

Available from:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC code:

B02BD02

INN (International Name):

FACTOR VIII, HUMAN 50 IU/ml

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

FACTOR VIII, HUMAN 50 IU/ml

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2010-07-06

Patient Information leaflet

Page 1 of 9
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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 products.
DO NOT USE OCTANATE
if you are allergic to human blood coagulation factor VIII or to any
of the other ingredients of
this medicine (listed in section 6).
Page 2 of 9
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WARN

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Octanate 50 IU/ml Powder and solvent for solution for injection
Octanate 100 IU/ml Powder and solvent for solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octanate 50 IU/ml
Each vial contains nominally either 250 IU or 500 IU human coagulation
factor VIII.
The product contains approximately 50 IU* per ml human coagulation
factor VIII when reconstituted
with the supplied solvent (5 ml for 250 IU/vial and 10 ml for 500
IU/vial).
The product contains approximately ≤ 30 IU per ml von Willebrand
factor (VWF:RCo).
Octanate 100 IU/ml
Each vial contains nominally 1000 IU human coagulation factor VIII.
The product contains approximately 100 IU* per ml human coagulation
factor VIII when reconstituted
with 10 ml of solvent.
The product contains approximately ≤ 60 IU per ml von Willebrand
factor (VWF:RCo).
*
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The specific
activity is ≥ 100 IU/mg protein.
Produced from the plasma of human donors.
Excipient with known effect:
250 IU/vial: less than 1 mmol sodium (23 mg) per dose, i.e.
essentially `sodium-free`
500 IU/vial: Sodium up to 1.75 mmol (40 mg) per dose
1000 IU/vial: 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.
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).
Octanate can be used for all age groups.
This preparation does not contain von Willebrand factor in
pharmacologically effective quantities and
is therefore not indicated in von Willebrand’s disease.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a