Octanate LV 100 IU/ml

Land: Verenigd Koninkrijk

Taal: Engels

Bron: myHealthbox

Werkstoffen:

human coagulation factor VIII, Willebrand factor (VWF:RCo)

Beschikbaar vanaf:

Octapharma Limited

ATC-code:

B02BD02

INN (Algemene Internationale Benaming):

human coagulation factor VIII, Willebrand factor (VWF:RCo)

Dosering:

500IU, 60IU

farmaceutische vorm:

Powder and solvent for solution for injection

Toedieningsweg:

intravenous route

Eenheden in pakket:

one 100IU/ml vial

Prescription-type:

POM - Prescription Only Medicine

Geproduceerd door:

Octapharma Pharmazeutika Produktionsges.m.b.H

Therapeutische categorie:

antihemorrhagics: blood coagulation factor VIII

therapeutische indicaties:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)

Autorisatie-status:

Authorised

Autorisatie datum:

2014-11-13

Bijsluiter

bleeding may continue. In such RARE cases, it is recommended that
a specialised haemophilia 
centre be contacted immediately. You should be
carefully monitored for the development of 
inhibitors by appropriate clinical observations and laboratory tests.Inhibitors may increase the 
risk of suffering severe allergic reactions (anaphylactic shock). If
you suffer an allergic reaction, 
you should be tested for the presence of an inhibitor. 
For information on viral safety see section 2. (Take special care
with Octanate LV - Information 
about the blood and plasma used for Octanate LV).
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible 
side effects not listed in this leaflet. You can also report side
effects directly via www.mhra.
gov.uk/yellowcard. By reporting side effects you can help provide
more information on the 
safety of this medicine.
5.  HOW TO STORE OCTANATE LV
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date 
refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vials in the outer carton in order to protect from light.
Use the reconstituted solution immediately and for single use only.
Do not use this medicine if you notice cloudy or incompletely
dissolved solutions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist 
how to throw away medicines you no
longer use. These measures will help protect the 
environment.
6.  CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT OCTANATE LV CONTAINS
The ACTIVE SUBSTANCE is the human blood coagulation factor VIII. 
Volume and concentrations
Octanate LV
®
 powder 
vial size (IU FVIII)
Solvent vial size 
(to be added to Octanate 
LV
®
 powder vial) (ml)
Nominal concentration of 
reconstituted solution  
(IU FVIII/ml)
500

Productkenmerken

octanateLV
Summary of Product Characteristics Updated 18­Aug­2015 | Octapharma Limited
1. Name of the medicinal product
Octanate LV 100 IU/ml
Octanate LV 200 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).
Octanate LV 200 IU/ml contains nominally 1000 IU human coagulation factor VIII per vial.
The product contains approximately 200 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 ≤ 120 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
Tre