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BETAFACT 50IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): HUMAN COAGULATION FACTOR IX

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Frequency of injections
(hours)/
Treatment time (days)

20 to 40

Repeat every 24 hours for at
least 1 day, until the pain has
resolved or-bleeding has
stopped.

Reconstitution:
Reconstitute the preparation with water for injections as described below.
Use current guidelines for aseptic procedure.
SOLVENT

POWDER

SOLVENT

POWDER

POWDER





Life threatening
haemorrhages

60 to 100

SOLVENT



POWDER







Repeat injection every 24
hours for 3 - 4 days or more
until range of movement
returns and pain has stopped.

SOLVENT

• Remove the protective cap from the solvent vial (water for injections)
and from the powder vial.
• Disinfect the surface of each stopper.

POWDER

SOLVENT

POWDER

SOLVENT
SOLVENT

POWDER
POWDER

SOLVENT

Repeat the injection every 8
to 24 hours until bleeding is
controlled.

POWDER

•  Remove the translucent protective sheath from the transfer
system and completely insert the exposed needle through the
centre of the stopper of the solvent vial while simultaneously
twisting the needle.

SOLVENT





30 to 60

SOLVENT



SOLVENT
SOLVENT
SOLVENT

view from above

SOLVENT
SOLVENT
SOLVENT
SOLVENT
SOLVENT
SOLVENT
POWDER

Under certain circumstances, larger amounts of BETAFACT than those
calculated may be required, particularly for the starting dose.
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. In the case of major surgical interventions in
particular, precise monitoring of the substitution therapy by means
of coagulation analysis (plasma factor IX activity) is indispensable.
Individual patients may vary in their response to factor IX,
demonstrating different half-lives and recoveries.
For long term prophylaxis for severe haemophilia B, the recommended
dose is 20 to 40 IU of BETAFACT per kg of body weight to be
administered every 3 to 4 days.
In certain cases, especially in young patients, it maybe necessary to
increase the dose or shorten the time between two injections.
Patients should be monitored for the development of factor IX inhibitors. If
the expected factor IX activity plasma levels are not attained, or if bleeding
is not controlled with an appropriate dose, an assay should be performed
to determine if a factor IX inhibitor is present. If the inhibitor is present
at levels less than 10 Bethesda Units (BU) per ml, administration of
additional human coagulation factor IX may neutralise the inhibitor.
In patients with inhibitor titres above 10 BU or with high anamnestic
response, the use of (activated) prothrombin complex concentrate (aPCC)
or activated factor VII (FVIIa) has to be considered. These therapies
should be directed by physicians with experience in the care of patients
with haemophilia.
In a clinical trial, 13 children less than 6 years old have been treated
with BETAFACT, for them the dosage is similar to that administered in
adults.

POWDER
POWDER
POWDER
POWDER

POWDER

POWDER
POWDER
POWDER
POWDER

view from above
SOLVENT

Repeat injections every 8 to
24 hours until adequate wound
healing; continue treatment for
at an additional 7 days
maintaining a factor IX activity
between 30% and 60% (IU/dl).

view from above
view from above
view from above
view from above
SOLVENT
SOLVENT
SOLVENT
SOLVENT

80 to 100
(pre- and
post-surgery)

Every 24 hours, for at least
1 day, until bleeding has
stopped.

SOLVENT

Major surgery

30 to 60

POWDER

SOLVENT

Surgery
Minor surgery including
tooth extraction

50 IU/ml





Extensive
haemarthrosis,
muscle haemorrhage
or haematoma.

• If necessary, bring the two vials (powder and solvent) to ambient
temperature.

POWDER
POWDER



SOLVENT



BETAFACT

POWDER

SOLVENT
SOLVENT
SOLVENT





Haemorrhage
Early
haemarthrosis,
muscle haemorrhage or
oral bleeding.

Target plasma
factor IX levels
(%)(IU/dl)

Powder and solvent for solution for injection
Human coagulation factor IX

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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.

in patients with signs of degradation of blood clots (fibrinolysis),
in patients presenting with the formation of multiple clots in the
circulating blood (disseminated intravascular coagulation),
in new-born babies,
if you just underwent a surgery,
if your blood coagulation is abnormally high,
if you have a liver disease.
Your doctor will ask you to undergo blood tests to detect the signs of these
complications as soon as possible.



Intensity of the bleeding/
Type of surgical

procedure

• Remove the second protective sheath from the other end of the
transfer system.
• Keeping both vials horizontal (vented spike pointing upwards),
quickly push the free end of the needle into the centre of the
stopper of the powder vial.
• Ensure that the needle always remains immersed in the solvent to
avoid releasing the vacuum prematurely.
•  Immediately place the system upright in a vertical position,
keeping the solvent vial directly above the powder vial, to allow the
solvent to transfer into the powder.
• During the transfer, direct the jet of solvent over the whole surface
of the powder. Ensure that all of the solvent is transferred.
• The vacuum is automatically released at the end of the transfer
procedure (sterile air).

POWDER

POWDER

• Remove the empty vial (solvent) with the transfer system.
•  Gently swirl for a few minutes with a rotating movement
to avoid the formation of foam until the powder has completely
dissolved.

What is in this leaflet:
1. What BETAFACT 50 IU/ml, is and what it is used for
2. What you need to know before you use BETAFACT
3. How to use BETAFACT
4. Possible side effects
5. How to store BETAFACT
6. Contents of the pack and other information

1. What BETAFACT is and what it is used for

POWDER
POWDER

The powder generally dissolves instantly and should be completely
dissolved in less than 5 minutes.
The solution should be clear.
Do not use a solution which is cloudy or has deposits.
Do not mix with other medicinal products.
Do not dilute the reconstituted product.
Administration:
Draw the product into a sterile syringe using the filter needle provided.
Remove the needle from the syringe.
Connect the syringe to an intravenous needle; expel the air from the
syringe, disinfect the skin over the vein and insert the needle.
Inject intravenously as a single dose immediately after reconstitution, at a
maximum rate of 4 ml/minute.
Storage after reconstitution:
For sterility reasons, the product should be used immediately. However
chemical and physical in-use stability has been demonstrated for 3 hours at
25°C after reconstitution.
POWDER
POWDER

POWDER

LFB BIOMEDICAMENTS
3, avenue des Tropiques - BP 305 - LES ULIS - 91958 Courtabœuf Cedex - FRANCE
Téléphone : +33 1 69 82 70 10
0000000-000000/0.0

4

BETAFACT is a medicine which belongs to the class of antihaemorrhagics.
The active substance is human coagulation factor IX, a protein which is
naturally present in the body. The role of this protein is to ensure normal
coagulation of the blood and to prevent that bleeding lasts too long.
BETAFACT is used to compensate for the lack of coagulation factor IX and, thus,
prevent and treat bleeding (haemorrhages) in patients with haemophilia B.
Haemophilia B is a hereditary disease characterised by a lack of a
protein called coagulation factor IX. This lack causes coagulation disorders.

2. What you need to know before you use BETAFACT
Do not use BETAFACT
If you are allergic to the active substance (factor IX) or any of the other
ingredients of this medicine (listed in section 6. “Contents of the pack and other
information”).
If you are allergic to heparin or its derivatives.
If you have in the past had a fall in your platelet count because of a medicine
containing heparin.
If your doctor has told you that you are allergic to heparin, contact him/her
before taking this medicine.
Your doctor should evaluate the possible benefits of treatment with BETAFACT
because of the risk of abnormal formation of clots in the blood (thromboembolic
complications)

Risk of allergic reactions
Due to the risk of allergies (see section 4. “Possible side effects”) during the
administration of factor IX, the first injections of BETAFACT must be performed
under medical supervision to provide immediate treatment for allergies, if
necessary.
Your doctor will inform you of the warning signs of an allergic reaction
(see section 4. “Possible side effects”). If one of these effects does occur,
immediately stop the treatment and alert a doctor to start appropriate treatment
depending on the type and severity of the reaction.
After repeated treatments with BETAFACT, your immune system
may react to factor IX by producing inhibitors (anti-factor IX antibodies).
The appearance of such inhibitors could reduce the treatment’s
efficacy. Your doctor must regularly perform blood tests to control for the
appearance of these inhibitors and measure their quantity.
A link has been demonstrated between the presence of factor IX
inhibitors and the occurrence of allergic reactions. Therefore:
If you present with allergic reactions following the use of factor IX, tests for
inhibitors must be performed.
If factor IX inhibitors are detected, there is a greater risk of developing a
severe allergic reaction during the injection of factor IX.
BETAFACT contains traces of human proteins other than factor IX. These
proteins could also play a role in the appearance of allergic reactions.
Information on safety measures due to the origin of BETAFACT
BETAFACT is manufactured from human plasma (the liquid part of blood).
When medicines are made from human blood or plasma, certain
measures are put in place to prevent infections being passed on to patients.
These include:
careful selection of blood and plasma donors to make sure those at risk of
carrying infections are excluded,
the testing of each donation and pools of plasma for the signs of virus
infections.
The inclusion of steps in the processing of the blood or plasma that can
inactivate or remove viruses.

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Despite these measures, when medicines prepared from human blood or plasma
are administered, the possibility of passing on infection cannot be totally excluded.
This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human
immunodeficiency virus (HIV or AIDS virus), hepatitis B virus and hepatitis C virus.
The measures taken may be of limited value against non-enveloped viruses
such as hepatitis A virus and parvovirus B19. Parvovirus B19 infection may be
serious pregnant women (fetal infection) and for individuals whose immune system
is depressed or who have some types of anaemia (e.g. sickle cell disease or
haemolytic anaemia).
Your doctor may recommend that you consider vaccination against hepatitis A and
B if you regularly/repeatedly receive human plasma-derived factor IX products.
It is strongly recommended that every time you receive a dose of BETAFACT, the
name and batch number of the medicine are recorded in order to maintain a record
of the batches used.
Children
The listed warnings and precautions apply both to adults and children.
Other medicines and BETAFACT
Please tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines, including medicines obtained without a prescription.
No interactions between BETAFACT and other medicines have been observed
to date.
Pregnancy and breast-feeding
The use of BETAFACT has not been evaluated in women who are pregnant or
breast-feeding.
If you are pregnant or breast-feeding, your doctor should evaluate the benefits
of treatment with BETAFACT. The potential benefit of this treatment should be
compared with the risks involved.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Nothing suggests that factor IX has an effect on the ability to drive or use machines.
BETAFACT contains sodium
This medicine contains around 2.6 mg of sodium per ml of product (13 mg per 5 ml
vial, 26 mg per 10 ml vial, 52 mg per 20 ml vial). You should take this into account
if you are on a salt-free or low-salt diet.
BETAFACT contains heparin
This medicine can cause allergic reactions and a fall in the number of blood cells,
which may affect coagulation.

3. How to use BETAFACT
Treatment should be initiated under the supervision of a physician experienced in
the treatment of haemophilia.
Dose
Your doctor will indicate the appropriate dose of BETAFACT.
The appropriate dose and frequency depend on the following:
 your weight,
 the severity of your haemophilia,
 the location and extent of bleeding,
your health condition,
 and, in certain cases, the operation you are to undergo (e.g.: surgical
procedure, tooth extraction, etc.).

Your doctor will recommend that you undergo blood tests during
treatment to control:
 factor IX levels,
 the presence of factor IX inhibitors.
Based on the results of these tests, your doctor may decide to adapt the dose and
frequency of your injections.
The appropriate dose is expressed in the number of units (IU).
Frequency of administration
Your doctor will indicate how often BETAFACT injections must be
administered.
Your doctor will adapt the frequency of the injections for you based on the severity
of your bleeding and the efficacy of the treatment.
A table describing the frequency and duration of treatment for various situations
is shown at the end of this leaflet in the section reserved for health professionals.
Mode and route of administration
This medicine should be injected into the veins by infusion.
If you have further questions on use of this product, ask your doctor or pharmacist.
If you use more BETAFACT than you should
Immediately contact your doctor or pharmacist.
However, no case of overdose has been reported with human
coagulation factor IX.
If you forget to use BETAFACT
Do not use a double dose to make up for a forgotten dose.

4. P
 ossible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Risk of allergic reactions
 H
 ypersensitivity or allergic reactions can occur rarely. In some cases, these
reactions have progressed to a serious allergic reaction.
 A
 llergic reactions may occur together with the development of factor IX inhibitor
and may affect kidney function (see also section 2. “Risk of allergic reactions”).
The warning signs of allergic reactions are :
 s welling of the face or throat,
 feeling of burning and tingling at the injection site,
 c hills,
 r edness,
 itching and rash,
 low blood pressure,
 e xtreme fatigue (lethargy),
 feeling sick (nausea), vomiting,
 r estlessness,
 fast heart rate,
 tightness of the chest,
 p ins and needles,
 w
 heezing (asthma-like).
If one of these effects occurs, immediately stop the treatment and alert a
doctor to start appropriate treatment depending on the type and severity of the
reaction.
The following adverse reactions have been directly observed with Betafact
in clinical studies and can occur rarely (may affect up to 1 in 1,000
injections) :

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· h ypersensitivity and allergic reactions (see also section 2 and 4 “Risk of allergic
reactions”),
· headache,
· pruritus
· allergic oedema
· feeling sick (nausea),
· injection reactions (malaise, chest pain),
· reaction at injection site.
Two cases of activity–neutralizing antibodies (inhibitors) in one previously
untreated patient and in one previously treated patient have been reported with
BETAFACT in the post-marketing period.
The following adverse reactions have not been observed in clinical studies
with Betafact but have been observed in patients using the same family
drug as Betafact:
Blood clots
Blood clots can occur with the use of low-purity factor IX preparations. It may:
· block the supply of blood and oxygen to the heart and cause heart attack.
· block the supply of blood and oxygen to the lungs and cause a serious condition
called pulmonary embolism,
· cause clot in a vein (venous thrombosis),
· cause blood clots inside the blood vessels throughout the body (disseminated
intravascular coagulation).
Betafact is a high-purity factor IX and it is rarely associated with this type of effect.
Inhibitors development
· Patients using factor IX preparations may develop anti-factor IX antibodies
(so-called inhibitors - see section 2. “Risk of allergic reactions”).
· These inhibitors were not observed in clinical trials performed with Betafact on
11 previously-untreated patients.
Reporting of side effects
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 ‘national reporting system’. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store BETAFACT
Keep this medicine out of the sight and reach of children.
Do not use this medecine after the expiry date which is stated on the vial label
and carton.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
The product should be used immediately after reconstitution.
For the purpose of ambulatory use, before opening, the product may be taken
out of the refrigerator, without being replaced, for a maximum period of 6 months
at a temperature not above 25°C. The date when the medicine is taken out and
the new expiry date should be written on the outer packaging. This new expiry
date should never exceed the one initially mentioned on the outer carton. If the
medicine has not been used before the new expiry date, it should be disposed of.
Do not use this medecine if the solution is cloudy or if it has deposits.
Do not throw away any medicine 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 BETAFACT contains
The active substance is human coagulation factor IX at the
concentration of 50 IU/ml after reconstitution. Once reconstituted with
5, 10 or 20 ml of water for injections, one vial contains 250 IU/5 ml,
500 IU/10 ml or 1000 IU/20 ml of human coagulation factor IX.
The specific activity of BETAFACT is an average of 110 IU/mg total
protein.
The other ingredients are:
sodium chloride, heparin sodium, lysine hydrochloride, arginine, sodium
citrate and water for injections : see section 2. “What you need to know
before you use BETAFACT”)
What BETAFACT 50 IU/ml, looks like and contents of the pack
BETAFACT is presented as a powder and a solvent for solution for
injection in glass vials, a transfer system and a filter needle.
BETAFACT is available in pack sizes of 250 IU/5 ml, 500 IU/10 ml and
1000 IU/20 ml.
Marketing Authorisation Holder and Manufacturer:
LFB-BIOMEDICAMENTS
3 avenue des Tropiques - BP 305 - Les Ulis
91958 Courtaboeuf Cedex - FRANCE
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria: BETAFACT 50 I.E./ml
Czech republic: BETAFACT 50 IU/ml
France: BETAFACT 50 UI/ml
Germany: BETAFACT 250 I.E./ 500 I.E./1000 I.E.
Greece: BETAFACT 50 IU/ml
Hungary: BETAFACT 50 NE/ml
Poland: BETAFACT 250 IU/500 IU/1000 IU
Portugal: BETAFACT 50 UI/ml
Romania: BETAFACT 50 UI/ml, pulbere si solvent pentru solutie injectabila
Slovak Republic: BETAFACT 50 IU/ml
Spain: BETAFACT 50 IU/ml
The Netherlands: BETAFACT 50 I.E/ml
United Kingdom: BETAFACT 50 IU/ml
This leaflet was last revised in

The following information is intended for healthcare professionals
only:
The appropriate dose is expressed in the number of units (IU) calculated
using the following equation:
Number of units to be administered = body weight (kg) x
target increase in factor IX levels (%) (IU/dL) x 0.93
Posology
For each of the bleeding episodes listed below, factor IX activity should not
fall below the given level in the corresponding period. This table can be
used to determine effective dosage in the following bleeding episodes and
surgeries:
0000000-000000/0.0

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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