Octanate 250IU

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

human blood coagulation factor VIII

Dostopno od:

Octapharma Pharmazeutika Produktionsges. m.b.H.

INN (mednarodno ime):

human blood coagulation factor VIII

Odmerek:

250IU/vial

Farmacevtska oblika:

powder lyophilized for solution for injection

Tip zastaranja:

Prescription

Navodilo za uporabo

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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.
•
Please keep this leaflet. You may need to read it again.
•
If you have further questions, please 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.
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.
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DO NOT USE OCTANATE
•
if you are allergic to human blood coag

Lastnosti izdelka

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INSTRUCTION FOR USE
(Summary of Product Characteristics)
1
NAME OF THE MEDICINAL PRODUCT
OCTANATE 250, 250 IU powder and solvent for solution for injection
OCTANATE 500, 500 IU powder and solvent for solution for injection
OCTANATE 1000, 1000 IU powder and solvent for solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OCTANATE 250 IU is presented as powder and solvent for solution for
injection containing
nominally 250 IU human coagulation factor VIII per vial.
The product contains approximately 50 IU* per ml human coagulation
factor VIII when reconstituted
with 5 ml of solvent. The product contains approximately ≤ 30 IU per
ml von Willebrand factor
(VWF:RCo).
OCTANATE 500 IU is presented as powder and solvent for solution for
injection containing
nominally 500 IU human coagulation factor VIII per vial.
The product contains approximately 50 IU* per ml human coagulation
factor VIII when reconstituted
with 10 ml of solvent. The product contains approximately ≤ 30 IU
per ml von Willebrand factor
(VWF:RCo).
OCTANATE 1000 IU is presented as powder and solvent for solution for
injection containing
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. The product contains approximately ≤ 60 IU
per ml von Willebrand factor
(VWF:RCo)
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially `sodium-
free` for 1 vial OCTANATE 250 IU and up to 1.75 mmol sodium (40 mg)
per dose for 1 vial
OCTANATE 500 IU and 1000 IU, respectively. To be taken into
consideration by patients on a
controlled sodium diet.
For a 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.
A white or pale yellow powder or friable sol