Octanate LV Pdr+Solv for Soln for Inj 100IU/ml

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

FACTOR VIII, HUMAN

Доступна з:

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

Код атс:

B02BD02

ІПН (Міжнародна Ім'я):

FACTOR VIII, HUMAN 100 IU/ml

Фармацевтична форма:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Склад:

FACTOR VIII, HUMAN 100 IU/ml

Тип рецепту:

POM

Терапевтична области:

ANTIHEMORRHAGICS

Статус Авторизація:

Authorised

Дата Авторизація:

2014-10-17

інформаційний буклет

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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 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 LV
if you are allergic to human blood coagulation factor VIII or to any
of the other ingredients of
this medicine (listed in sec

Характеристики продукта

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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
OCTANATE LV 200 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octanate LV 100 IU/ml
Each vial contains nominally 500 IU human coagulation factor VIII.
The product contains approximately 100 IU* per ml human coagulation
factor VIII when reconstituted
with 5 ml of solvent.
The product contains approximately ≤ 60 IU per ml von Willebrand
factor (VWF:RCo).
Octanate LV 200 IU/ml
Each vial contains nominally 1000 IU human coagulation factor VIII.
The product contains approximately 200 IU* per ml human coagulation
factor VIII when reconstituted
with 5 ml of solvent.
The product contains approximately ≤ 120 IU per ml von Willebrand
factor (VWF:RCo).
* The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The mean
specific activity of Octanate LV is ≥ 100 IU/mg protein.
Produced from the plasma of human donors.
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.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white or pale yellow, also appearing as a friable mass.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a physician experienced
in the treatment of haemophilia.
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Treatment monitoring
During the course of treatment, appropriate determination of factor
VIII levels is advised to guide the
d