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HUMAN PLASMA DERIVED COAGULATION FACTOR VIII

Active substance(s): HUMAN COAGULATION FACTOR VIII

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Package leaflet: Information for the user

Haemoctin® 250 / Haemoctin® 500 / Haemoctin® 1000
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 signs of illness 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 is and what it is used for
2. What you need to know before you use Haemoctin
3. How to use Haemoctin
4. Possible side-effects
5. How to store Haemoctin
6. Contents of the pack and other information
1. What Haemoctin is and what it is used for

185391 004

Haemoctin 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 / 1000 IU packaging sizes) of water for
injections the solution is ready for intravenous injection.
Haemoctin is used for treatment and prophylaxis of bleeding in patients
with haemophilia A (congenital factor VIII deficiency).
Haemoctin does not contain von Willebrand factor in pharmacologically
effective quantities, and is therefore not suitable for the treatment of von
Willebrand's disease.
2. What you need to know before you use Haemoctin
Do not use Haemoctin,
- if you are allergic to coagulation factor VIII or to any of the other

ingredients of this medicine (listed in section 6). An allergic reaction may
include rash, itching, difficulty breathing or swelling of the face, lips, throat or
tongue.
Warnings and precautions
If you start the treatment with Haemoctin, it is possible that your immune system
develops antibodies (inhibitors) to factor VIII. These inhibitors may impact the
effect of Haemoctin. 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 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).
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
the name and batch number of the medicine are recorded in order to maintain a
record of the batches used.
Other medicines and Haemoctin

Tell your doctor if you are using, have recently used or might use any other
medicines.
Interactions between Haemoctin 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 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.
Haemoctin 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.
Haemoctin 1000: 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
Haemoctin is intended for intravenous administration (injection into a vein).
Treatment should be initiated under the supervision of a physician experienced in
the treatment of haemophilia A. Always use Haemoctin 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.

Ensure sterile working in all steps of the procedure.

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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.

- 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 use more Haemoctin than you should
If you believe that you have been given too much Haemoctin, tell your doctor, who
will decide about further treatment.
If you forget to use Haemoctin
In this case your doctor will decide whether a further treatment is necessary.
If you stop using Haemoctin
Do not stop using Haemoctin without consulting your doctor.
If you have any further questions on the use of this product, 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 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.
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
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
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 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 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 looks like and contents of the pack
Haemoctin is supplied as a freeze-dried powder (lyophilisate). Water for injections
serves as solvent. The dissolved product is clear or slightly opalescent.
Haemoctin 250 contains 1 vial with 250 IU and 1 vial with 5 ml water for
injections (50 IU/ml)
Haemoctin 500 contains 1 vial with 500 IU and 1 vial with 10 ml water for
injections (50 IU/ml)
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
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 leaflet was last revised in 01/2016.
The following information is intended for healthcare professionals only:
Method of administration:
Haemoctin is intended for intravenous injection. It is recommended not to
administer more than 2-3 ml per minute.
Dosage
The dosage and duration of the substitution therapy depend on the severity of
the factor VIII deficiency, on the location and extent of the bleeding and on the
patient's clinical condition.

The number of units of factor VIII administered is expressed in International Units
(IU), which are related to the current WHO standard for factor VIII products. Factor
VIII 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 VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity
of factor VIII in one ml of normal human plasma. The calculation of the required
dosage of factor VIII is based on the empirical finding that 1 International Unit
(IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1 % to
2 % of normal activity.
The required dosage is determined using the following formula:
Required units = body weight (kg) * desired factor VIII rise (%) * 0.5
The amount to be administered and the frequency of administration should
always be oriented to the clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, the factor VIII activity should
not fall below the given plasma activity level (in % of normal) 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 VIII level Frequency of doses (hours) /
required (%)
Duration of therapy (days)

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

Repeat every 12 to 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 every 12 to 24 hours for
3 - 4 days or more until pain and
acute disability are resolved.

Life threatening
haemorrhages

60 - 100

Repeat 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 every 8 to 24 hours until
adequate wound healing, then
therapy for at least another
7 days to maintain a factor VIII
activity of 30 - 60%.

Surgery
Minor
including tooth extraction
Major

During the course of treatment, appropriate determination of factor VIII 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 VIII activity) is indispensable. Individual patients may vary in their response
to factor VIII, achieving different levels of in vivo recovery and demonstrating
different half-lives.
For long term prophylaxis against bleeding in patients with severe haemophilia A,
the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of
2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals
or higher doses may be necessary.
Patients should be monitored for the development of factor VIII inhibitors. If the
expected factor VIII 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 VIII inhibitor is present. In patients with high levels of inhibitor, factor VIII
therapy may not be effective, and other therapeutic options should be considered.
Management of such patients should only be directed by doctors with experience
in the care of patients with haemophilia.

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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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