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HAEMONINE 500 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): HUMAN COAGULATION FACTOR IX

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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.

185342 002

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 joints, muscles or internal organs. You may have this condition from birth or
acquire it later in life. The administration of Haemonine can compensate for this
deficiency.
2. What you need to know before you use Haemonine
Do not use Haemonine:
• if you are allergic to coagulation factor IX, to any of the other ingredients of this
medicine (listed in section 6) or to heparin.
Usually, if you are allergic to Haemonine it will show up within the first
applications. The early signs of hypersensitivity reactions include reddening of
the skin, nettle rash, itching over the entire body, swelling of lips and tongue,
breathing difficulties, tightness of the chest, wheezing, drop in blood pressure,
loss of consciousness, which can progress to severe allergic reactions (see also
section "Possible side effects"). If you detect one or more of the symptoms listed
above in yourself, call your doctor instantly.
Warnings and precautions
Talk to your doctor or pharmacist before using Haemonine
• Before you use Haemonine you should tell your doctor if you know that you
have a risk of thrombosis or you have had thromboembolic complications in
the past, if you suffer from liver disease or if a surgery is planned. These are
conditions that increase your risk of developing internal blood clots, even if
you have not been injured. If you are unsure, you should discuss this with your
doctor. If you are taking medicines which have an impact on the clotting of the
blood please talk to your doctor. The risk for developing internal blood clots
might be increased.
• If you have existing cardiovascular risk factors, therapy with Haemonine may
increase the cardiovascular risk. If you are unsure, you should discuss this with
your doctor.
• Allergic-type hypersensitivity reactions are possible with Haemonine. Please
contact immediately your doctor or Haemophilia center if you experience early
signs of hypersensitivity/allergic reactions like (generalised) hives, tightness of
the chest, wheezing, low blood pressure or anaphylaxis (severe allergic reaction
such as difficulty in swallowing and/or breathing, low blood pressure, red or
swollen face and/or hands) (see also section "Possible side effects").
• Please contact immediately your doctor or Haemophilia center if your bleeding
does not stop as expected or if you experience a significant increase in your
usage of Haemonine in order to control a bleed. Your doctor will do a blood
test to check if you have developed neutralising antibodies (inhibitors) against
your medicine. The risk for developing inhibitors is highest in patients who
have not been treated with a factor IX replacement medicine before or in the

early phases of treatment, i.e. for small children (see also section "Possible side
effects").
• Inhibitors may develop together with allergies. Patients with factor IX inhibitors
may be at an increased risk of anaphylaxis during future treatment with factor IX.
• 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, and the testing of each donation and pools
of plasma for signs of virus/infections. Manufacturers of these products also
include steps in the processing of the blood or plasma that can inactivate or
remove viruses. Despite these measures, when medicines prepared from human
blood or plasma are administered, the possibility of passing on infection cannot
totally be 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), hepatitis B virus and hepatitis C virus,
and for the non-enveloped hepatitis A virus. The measures taken may be of
limited value against non-enveloped viruses such as parvovirus B19. Parvovirus
B19 infection may be serious for 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 Haemonine
the name and batch number of the product are recorded in order to maintain a
record of the batches used.
Children
There are insufficient data to recommend the use of Haemonine in children less
than 6 years of age.
Other medicines and Haemonine
Tell your doctor or pharmacist if you are using, have recently used or might use
any other medicines.
No interactions of Haemonine with other medicinal products are known.
Pregnancy and breast-feeding
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 this
medicine. If you have already told your doctor then follow any instructions that
may have been given to you.

Haemophilia B in women is rare. Therefore there is no experience regarding the
use of Haemonine during pregnancy and breast-feeding.
Driving and using machines
Haemonine has no or negligible influence on the ability to drive and use machines.
Haemonine contains sodium
This medicinal product contains a maximum of 4.9 mmol (113 mg) sodium
per standard dose of 2,000 IU. To be taken into consideration by patients on a
controlled sodium diet.
3. How to use Haemonine
Always use this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Haemonine treatment should always be on supervision of a doctor who has
experience in the treatment of haemophilia.
Dosage and Frequency of Administration
The amount of Haemonine you need to use depends on your weight, the severity
of your haemophilia, the site and severity of your bleed, and the need to prevent
bleeding, for example before dentistry or an operation.
Your doctor will calculate the dose of Haemonine and how often you need to
inject it to obtain the correct levels in your blood. Do not use higher doses than
your doctor has told you.
The number of units of factor IX administered is expressed in International Units
(IU), which are related to the current WHO standard for factor IX products. Factor
IX activity in plasma is expressed either as a percentage (relative to normal human
plasma) or in International Units (relative to an International Standard for factor
IX in plasma).
On demand treatment
One International Unit (IU) of factor IX activity is equivalent to that quantity
of factor IX in one ml of normal human plasma. The calculation of the required
dosage of factor IX is based on the empirical finding that 1 IU factor IX per kg body
weight raises the plasma factor IX activity by 1-2 % of normal activity. The required
dose is determined using the following formula:
Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.8
In the case of the following haemorrhagic events, the factor IX activity should
not fall below the given plasma activity level (in % of normal or in IU/dl) in the
corresponding period. The following table can be used to guide dosing in bleeding
episodes and surgery:

Degree of haemorrhage/
Type of surgical procedure

Factor IX level
required (%)
(IU/dl)

Haemorrhage
Early haemarthrosis, muscle 20 - 40
bleeding or oral bleeding

Frequency of doses (hours)/
Duration of therapy (days)

Repeat every 24 hours. At least
1 day, until the bleeding episode
as indicated by pain is resolved
or healing is achieved.

More extensive
haemarthrosis, muscle
bleeding or haematoma

30 - 60

Repeat infusion every 24 hours
for 3 - 4 days or more until pain
and acute disability are resolved.

Life threatening
haemorrhages

60 - 100

Repeat infusion every 8 to
24 hours until threat is resolved.

30 - 60

Every 24 hours, at least 1 day,
until healing is achieved.

80 - 100
(pre- and postoperative)

Repeat infusion every 8 to
24 hours until adequate wound
healing, then therapy for at least
another 7 days to maintain a
factor IX activity of 30 to 60%
(IU/dl).

Surgery
Minor surgery
including tooth extraction
Major surgery

Prophylaxis
For long term prophylaxis against bleeding in patients with severe haemophilia
B, the usual doses are 20 to 40 IU of factor IX per kilogram of body weight at
intervals of 3 to 4 days. In some cases, especially in younger patients, shorter
dosage intervals or higher doses may be necessary.
It is recommended to not exceed a maximal infusion rate of 5 ml/min.
If you have the impression that the effect of Haemonine is too weak, talk to your
doctor. You may have developed antibodies to factor IX (see section "Warnings and
precautions" and "Possible side effects").
Paediatric population
Your doctor will calculate the dose of Haemonine and how often you need to
inject it to obtain the correct levels in your blood.

If you use more Haemonine than you should
No case of overdose with human coagulation factor IX has been reported.
If you forget to use Haemonine
Do not take a double dose to make up for a forgotten dose.
If you stop using Haemonine
Do not stop using Haemonine without discussing this with your doctor. Always
use Haemonine exactly as your doctor has told you.
Instructions for use
Haemonine is given by injection into a vein (intravenous use). If you have been
prescribed Haemonine to use at home, your doctor or haemophilia centre nurse
will have to make sure that you know how to use it.
If you are in any doubt about injecting Haemonine, go back to your doctor or
Haemophilia Centre for more advice and training before attempting to give
yourself any treatment. Follow the directions given to you by your doctor or
haemophilia nurse.
During the preparation and injection of Haemonine, it is important to use sterile
conditions.
Haemonine must not be mixed with other medicinal products.
Use only the provided injection set, otherwise treatment may not be efficient due
to factor IX adsorption to the internal surfaces of some other injection equipment.

Fig. 1

Fig. 2

Fig. 3

Dissolution of the concentrate:
• Bring the unopened vials of the solvent (water for
injections) and product to room temperature. If a water
bath is used for warming, it must be scrupulously ensured
that the water does not come into contact with the caps
or stoppers of the vials. Otherwise contamination of the
medicine may occur.
• Remove the caps from both vials in order to expose the
central portions of the rubber stoppers. Ensure that the
rubber stoppers of the product and solvent vials are
treated with a disinfectant
• Remove the top of the transfer system packaging (2)
Place the blue part of the transfer system onto the upright
standing vial containing the solvent (3).
• Remove the remaining part of the packaging of the
transfer system. Now the transparent part of the transfer
system is visible.

Fig. 4

Fig. 5

Fig. 6

Fig. 7

• Place the product vial on an even surface.
• Turn the combination of transfer system and solvent vial
upside down. Push the spike of the transparent part of the
adapter straight down through the product vial stopper (4).
The vacuum present in the product vial causes the solvent
to flow into the product vial. (5) Immediately unscrew the
blue part of the transfer system together with the solvent
vial. Discard the solvent vial with the blue part of the
transfer system attached (6). Gently swirling the product
vial helps in dissolving the powder. Do not shake vigorously,
all foaming is to be avoided! The solution is clear or slightly
opalescent.
• The solution ready for use must be used immediately
after dissolving. Do not use solutions that are cloudy or
have deposits.
Injection:
• Once you have dissolved the powder as described above,
screw the enclosed syringe with its Luer-Lock connector
onto the product vial with the transparent part of the
transfer system. (7) This allows you to easily draw the
dissolved drug into the syringe. A separate filter is not
necessary because the transfer system has its own integral
filter.
• Carefully disconnect the vial with the transparent part
of the transfer system from the syringe. Use the enclosed
butterfly needle and administer immediately by slow
intravenous injection. The injection rate must not exceed
2-3 ml/minute.
• After the butterfly needle has been used, it can be made
safe with the protective cap.

If you have any further questions on the use of the medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

If you experience one of the following conditions please contact immediately
your doctor or Haemophilia center (see also section "Warnings and
precautions")
• Hypersensitivity or anaphylactic reactions (which may include swelling
of the face, tongue or throat, difficulty in swallowing and breathing, back
pain, chest discomfort, chills, dyspnoea, flushing, hives, headache, low blood
pressure, injection site reactions (e.g. rash and pain), lethargy, nausea,
itching, rash, restlessness, rapid heartbeat, abnormal sensation, vomiting,
wheezing)
• Severe anaphylactic reactions (including anaphylactic shock)
• Bleeding; this might be associated with the development of neutralising
antibodies (inhibitors) to factor IX.
The following side effects have been reported with human coagulation factor IX
products:
• Nephrotic syndrome (a disorder where the kidneys are damaged) has been
reported in haemophilia B patients with a history of allergic reaction.
• There is a small risk of thromboembolic episodes (blood clots).
• Haemonine may contain traces of heparin which may cause allergic reactions
and reduced blood cell counts which may affect the blood clotting system.
Patients with a history of heparin-induced allergic reactions should avoid the
use of heparin-containing medicines.
The following side effects have been reported with Haemonine:
Very common (may affect more than 1 in 10 patiens):
• Hypersensitivity reactions, see above
Common (may affect up to 1 in 10 patients):
• Anxiety
• Abnormal increase in sensitivity (hyperaesthesia)
• Nausea
• Skin reactions (dermatitis allergic), hives (urticaria)
• Back pain
• Hot flush
• Shortness of breath (dyspnoea)
• Feeling cold, Injection site reaction (including e.g. pain and rash)
Not known (frequency cannot be estimated from the available data):
• Development of neutralising antibodies (inhibitors) to factor IX (factor IX
inhibition)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the national reporting system Yellow Card Scheme,
Website: 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 Haemonine
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 and the
outer carton.
Once opened or dissolved, use the product immediately.
Do not store above 25°C.
Do not freeze.
Keep the vials in the outer carton in order to protect from light.
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 Haemonine contains:
Powder:
The active substance is human coagulation factor IX. Each vial of Haemonine 500
contains 500 IU of human coagulation factor IX. Each vial of Haemonine 1000
contains 1000 IU of human coagulation factor IX.
The other ingredients are arginine, lysine, sodium chloride, and sodium citrate.
Solvent:
Water for injections
What Haemonine looks like and contents of the pack
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 must be clear or slightly opalescent
without any visible particles.

1 package Haemonine 500 contains:
• 1 glass vial with powder
• 1 glass vial with 5 ml water for injections
• 1 disposable syringe (5 ml)
• 1 double filter transfer system
• 1 butterfly cannula
1 package Haemonine 1000 contains:
• 1 glass vial with powder
• 1 glass vial with 10 ml water for injections
• 1 disposable syringe (10 ml)
• 1 double filter transfer system
• 1 butterfly cannula
Marketing Authorisation Holder and Manufacturer:
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
Phone: +49 6103 801-0
Fax: +49 6103 801-150
info@biotest.de
This leaflet was last revised in 04/2016.

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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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