OCTANATE 500 International Unit Pdr+Solv for Soln for Inj
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
13-12-2014
Summary of Product characteristics
(SPC)
04-08-2015
Active ingredient:
HUMAN COAGULATION FACTOR VIII
Available from:
Octapharma Limited
ATC code:
B02BD02
INN (International Name):
HUMAN COAGULATION FACTOR VIII
Dosage:
500 International Unit
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Blood coagulation factors
Authorization status:
Authorised
Authorization date:
2014-11-28
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTANATE LV 100 IU/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 recomme
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Octanate 500 IU powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Octanate 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 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 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 Wo
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