Helixate NexGen 500unit powder and solvent for solution for injection vials

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Octocog alfa

Dostopno od:

CSL Behring UK Ltd

INN (mednarodno ime):

Octocog alfa

Odmerek:

500unit

Farmacevtska oblika:

Powder and solvent for solution for injection

Pot uporabe:

Intravenous

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02110000; GTIN: 5028360000558

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HELIXATE NEXGEN 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Recombinant coagulation factor VIII (octocog alfa)
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 any further questions, ask your doctor or your pharmacist.
-
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Helixate NexGen is and what it is used for
2.
What you need to know before you use Helixate NexGen
3.
How to use Helixate NexGen
4.
Possible side effects
5.
How to store Helixate NexGen
6.
Contents of the pack and other information
1.
WHAT HELIXATE NEXGEN IS AND WHAT IT IS USED FOR
Helixate NexGencontains the active substance human recombinant
coagulation factor VIII
(octocog alfa).
Helixate NexGen is used for treatment and prophylaxis of bleeding
adults, adolescents and
children of all ages with haemophilia A (congenital factor VIII
deficiency).
This preparation does not contain von Willebrand factor and is
therefore not to be used in von
Willebrand's disease.
The vial contains a dry white to slightly yellow powder or cake, as
well as water for injections
to be used to reconstitute the contents of the vial.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HELIXATE NEXGEN
DO NOT USE HELIXATE NEXGEN
•
if you are allergic to octocog alfa or to any of the other ingredients
of this med

Lastnosti izdelka

OBJECT 1
HELIXATE NEXGEN 250 IU POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 08-Nov-2016 | CSL Behring
UK Limited
1. Name of the medicinal product
Helixate NexGen 250 IU powder and solvent for solution for injection
Helixate NexGen 500 IU powder and solvent for solution for injection
Helixate NexGen 1000 IU powder and solvent for solution for injection
Helixate NexGen 2000 IU powder and solvent for solution for injection
Helixate NexGen 3000 IU powder and solvent for solution for injection
2. Qualitative and quantitative composition
Each vial contains nominally 250/500/1000/2000/3000 IU human
coagulation factor VIII (INN: octocog
alfa).
Human coagulation factor VIII is produced by recombinant DNA
technology (rDNA) in baby hamster
kidney cells containing the human factor VIII gene.
• One mL Helixate NexGen 250 IU contains approximately 100 IU (250
IU / 2.5 mL) of recombinant
human coagulation factor VIII (INN: octocog alfa) after reconstitution
with water for injections.
• One mL Helixate NexGen 500 IU contains approximately 200 IU (500
IU / 2.5 mL) of recombinant
human coagulation factor VIII (INN: octocog alfa) after reconstitution
with water for injections.
• One mL Helixate NexGen 1000 IU contains approximately 400 IU (1000
IU / 2.5 mL) of recombinant
human coagulation factor VIII (INN: octocog alfa) after reconstitution
with water for injections.
• One mL Helixate NexGen 2000 IU contains approximately 400 IU (2000
IU / 5 mL) of recombinant
human coagulation factor VIII (INN: octocog alfa) after reconstitution
with water for injections.
• One mL Helixate NexGen 3000 IU contains approximately 600 IU (3000
IU / 5 mL) of recombinant
human coagulation factor VIII (INN: octocog alfa) after reconstitution
with water for injections.
The potency (IU) is determined using the one-stage clotting assay
against the FDA Mega standard which
was calibrated against WHO standard in International Units (IU).
The specific activity of Helixate NexGen is approximately 4000 IU/mg