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HAEMOCTIN 250 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

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Package leaflet: Information for the user

Haemoctin® 250 / Haemoctin® 500
Powder and solvent for solution for injection
Human plasma derived coagulation factor VIII

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, pharmacist or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Haemoctin 250 / Haemoctin 500 is and what it is used for
2. What you need to know before you use Haemoctin 250 / Haemoctin 500
3. How to use Haemoctin 250 / Haemoctin 500
4. Possible side-effects
5. How to store Haemoctin 250 / Haemoctin 500
6. Contents of the pack and other information

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1. What Haemoctin 250 / Haemoctin 500 is and what it is used for
Haemoctin 250 / Haemoctin 500 is a medicine derived from human plasma.
It contains the coagulation factor VIII, which is necessary for a normal course
of blood coagulation. After reconstitution of the powder with 5 ml (250 IU
packaging size) or 10 ml (500 IU packaging size) of water for injections the
solution is ready for intravenous injection.
Haemoctin 250 / Haemoctin 500 is used for treatment and prophylaxis of
bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Haemoctin 250 / Haemoctin 500 does not contain von Willebrand factor in
pharmacologically effective quantities, and is therefore not suitable for the
treatment of von Willebrand's disease.

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2. What you need to know before you use Haemoctin 250 / Haemoctin 500
Do not use Haemoctin 250 / Haemoctin 500,
- if you are allergic (hypersensitive) to coagulation factor VIII or to any of the
other ingredients (listed in section 6). An allergic reaction may include
rash, itching, difficulty breathing or swelling of the face, lips, throat or
tongue.

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Warnings and precautions
Talk to your doctor before using Haemoctin 250 / Haemoctin 500.
If you start the treatment with Haemoctin 250 / Haemoctin 500, it is possible that
your immune system develops antibodies (inhibitors) to factor VIII. These inhibitors may impact the effect of Haemoctin 250 / Haemoctin 500. Your doctor should
check you regularly using a biological test (the Bethesda test) for the formation of
inhibitors. The appearance of such factor VIII inhibitors manifests itself as a lack of
therapeutic success. The amount of inhibitors in the body is expressed in Bethesda
units (BU) per ml of blood plasma. The risk of developing inhibitors depends on the
administration of factor VIII, and is greatest during the first 20 days of administration. Inhibitors rarely form after more than 100 days of administration. Cases of recurrent inhibitors have been observed after switching from one factor VIII product
to another in previously treated patients with more than 100 exposure days who
have a previous history of inhibitor development.
Only the supplied infusion set should be used because treatment failure can occur
as a consequence of factor VIII adsorption to the internal surfaces of some infusion
equipment.
Haemoctin 250 / Haemoctin 500 must not be mixed with other medicinal products.
Catheter-related complications: If a central venous access device (CVAD) is required,
risk of CVAD-related complications including local infections, bacteraemia and
catheter site thrombosis should be considered.
Virus safety
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 signs of virus/infections,
- the inclusion of 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 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), 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).

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Your doctor may recommend that you consider vaccination against hepatitis A and
B if you regularly/repeatedly receive human plasma-derived Factor VIII products.
It is strongly recommended that every time you receive a dose of Haemoctin 250 /
Haemoctin 500 the name and batch number of the medicine are recorded in order
to maintain a record of the batches used.
Other medicines and Haemoctin 250 / Haemoctin 500
Tell your doctor if you are using, have recently used or might use any other medicines.
Interactions between Haemoctin 250 / Haemoctin 500 and other medicinal products are unknown.
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 for advice before taking this medicine.
Because of the rare occurrence of haemophilia A in women, there is no experience
available on the use of Haemoctin 250 / Haemoctin 500 during pregnancy or while
breast-feeding. No animal experiments have been performed during pregnancy
and nursing.
Driving and using machines
The ability to drive and operate machines is not impaired by the use of Haemoctin
250 / Haemoctin 500.
Haemoctin 250 / Haemoctin 500 contains sodium
Haemoctin 250: One vial contains up to 16.1 mg (0.70 mmol) sodium.
Haemoctin 500: One vial contains up to 32.2 mg (1.40 mmol) sodium.
Please take this into account if you are on a controlled sodium diet.
3. How to use Haemoctin 250 / Haemoctin 500
Haemoctin 250 / Haemoctin 500 is intended for intravenous administration (infusion into a vein). Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Always use Haemoctin 250 /
Haemoctin 500 exactly as your doctor told you. You should check with your doctor
if you are not sure. The dosage and duration of treatment depend on the severity
of the factor VIII deficiency, on the location and extent of the bleeding and on your
clinical condition. Your doctor will determine the dose which is suitable for you.

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Ensure sterile working in all steps of the procedure.

Fig. 1

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Fig. 6

Fig. 7

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Reconstitution of the powder:
- 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 (1). 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.
- 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 should be used immediately after
dissolving. Do not use solutions that are cloudy or contain
visible particles.
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.

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- 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. It is recommended not to administer more
than 2-3 ml/min.
- 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 this product, ask your doctor or
pharmacist.
If you use more Haemoctin 250 / Haemoctin 500 than you should
If you believe that you have been given too much Haemoctin 250 / Haemoctin 500,
tell your doctor, who will decide about further treatment.
If you forget to use Haemoctin 250 / Haemoctin 500
In this case your doctor will decide whether a further treatment is necessary.
If you stop using Haemoctin 250 / Haemoctin 500
Do not stop using Haemoctin 250 / Haemoctin 500 without consulting your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
If you notice any of the following effects, tell your doctor immediately:
- reddening of the skin,
- burning and stinging at the injection site
- chills
- flushing
- headache,
- hives,
- hypotension,
- lethargy,
- nausea,
- restlessness
- tachycardia,
- tightness of the chest,
- tingling,
- vomiting,
- wheezing
This can be an allergic or a serious allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

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The following other side effects have been observed very rarely (less than 1 user
in 10.000)
- Anti factor VIII antibody positive: Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response (e.g. bleeding). In such
cases, it is recommended that a specialised haemophilia centre be contacted.
- fever
- anaemia
- bleeding in the brain
Side effects in children and adolescents
Side effects in children are expected to be the same as in adults.
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 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 Haemoctin 250 / Haemoctin 500
Keep this medicine out of the sight and reach of children.
Keep the vials in the outer carton in order to protect from light.
Do not store above 25°C. Do not freeze.
Do not use Haemoctin 250 / Haemoctin 500 after the expiry date which is stated
on the label of the vial and the carton.
Any unused product or waste material should be disposed of in accordance with
local requirements. Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Haemoctin 250 / Haemoctin 500 contains
- The active substance is Human coagulation factor VIII
- The other ingredients are glycine, sodium chloride, sodium citrate and calcium
chloride.
- The solvent vial contains water for injections.
What Haemoctin 250 / Haemoctin 500 looks like and contents of the pack
Haemoctin 250 / Haemoctin 500 is supplied as a freeze-dried powder (lyophilisate).

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Water for injections serves as solvent. The dissolved product is clear or slightly opalescent.
Further pack sizes:
Haemoctin 1000: contains 1 vial with 1000 IU and 1 vial with 10 ml water for injections (100 IU/ml)
Each pack contains
- one disposable syringe
- one transfer system with integral filter
- one butterfly cannula
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
Phone: +49 6103 801-0
Fax: +49 6103 801-150
mail@biotest.de
This medicinal product is authorised in the Member States of the EEA under the
following names:
Czech Republic, Germany, Lithuania, Malta, Romania:
Haemoctin SDH 250 / Haemoctin SDH 500
Belgium, Greece, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom:
Haemoctin 250 / Haemoctin 500
Austria:

Haemoctin SDH 50 I.E./ml

Hungary:

Haemoctin 250 NE / Haemoctin 500 NE

Bulgaria:

Haemoctin 250 IU / Haemoctin 500 IU

This leaflet was last revised in 11/2014.
The following information is intended for healthcare professionals only:
Method of administration:
Haemoctin 250 / Haemoctin 500 is intended for intravenous injection. It is recommended not to administer more than 2-3 ml per minute.

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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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