Haemonine 500unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Factor IX high purity

Available from:

Biotest (UK) Ltd

ATC code:

B02BD04

INN (International Name):

Factor IX high purity

Dosage:

500unit

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02110000; GTIN: 04036124016845

Patient Information leaflet

HAEMONINE 500 AND 1000
PACKAGE LEAFLET UK
1 / 7
_ PACKAGE LEAFLET: INFORMATION FOR THE USER _
HAEMONINE
 500 / HAEMONINE
 1000
Powder and solvent for solution for injection
Human coagulation factor IX
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 Haemonine is and what it is used for
2.
What you need to know before you use Haemonine
3.
How to use Haemonine
4.
Possible side effects
5.
How to store Haemonine
6.
Contents of the pack and other information
1. WHAT HAEMONINE IS AND WHAT IT IS USED FOR
Haemonine is presented as a powder and a solvent for solution for
injection, available in two packaging
sizes. Each vial of Haemonine 500 contains 500 IU (international
units) of human coagulation factor IX.
In a separate vial, 5 ml water for injections are provided. Each vial
of Haemonine 1000 contains 1000
IU (international units) of human coagulation factor IX. In a separate
vial, 10 ml water for injections are
provided.
The specific activity of Haemonine is

70 IU/mg protein.
Haemonine is being prescribed TO STOP or PREVENT BLEEDING because of a
lack of factor IX (Haemophilia
B) in the blood in adults, adolescents and children aged 6 years and
older. Thus, Haemonine as a
coagulation factor IX preparation belongs to the pharmacotherapeutic
group of antihaemorrhagics.
Factor IX is a protein that is part of the body's natural way of
forming clots to stop bleeding. If it is
absent or low in your blood, you will suffer from blood coagulation
problems which may lead to
bleeding in jo

Summary of Product characteristics

OBJECT 1
HAEMONINE 500 / HAEMONINE 1000
Summary of Product Characteristics Updated 28-Jul-2016 | Biotest (UK)
Ltd
1. Name of the medicinal product
Haemonine
®
500
Haemonine
®
1000
Powder and solvent for solution for injection
2. Qualitative and quantitative composition
Human plasma derived coagulation factor IX;
Haemonine
®
is presented as a powder and solvent for solution for injection
containing either 500 or 1000
IU human coagulation factor IX per vial.
When reconstituted with either 5 ml or 10 ml water for injections,
Haemonine
®
contains approximately
100 IU/ml human coagulation factor IX.
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting test. The specific
activity of Haemonine
®
is ≥ 70 IU/mg protein.
Excipients with known effect: The reconstituted product contains 0.19
mmol – 0,245 mmol (4.37 mg –
5,63 mg) sodium per ml. For the full list of excipients, see section
6.1.
3. Pharmaceutical form
Powder and solvent for solution for injection.
White powder and clear, colourless solvent for solution for injection.
After dissolving the powder in the provided water for injections, the
Haemonine solution is clear or
slightly opalescent without any visible particles (see section 6.6).
4. Clinical particulars
4.1 Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia B
(congenital factor IX deficiency).
Haemonine is indicated in adults, adolescents and children aged 6
years and older.
4.2 Posology and method of administration
Treatment should be under the supervision of a physician experienced
in the treatment of haemophilia.
TREATMENT MONITORING
During the course of treatment, appropriate determination of factor IX
levels is advised to guide the dose
to be administered and the frequency of repeated infusions. Individual
patients may vary in their response
to factor IX, demonstrating different half-lives and recoveries. Dose
based on bodyweight may require
adjustment in underweight or overweight patients. In the case of major
surgical inte