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HAEMATE P 1000 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): FACTOR VIII HEAT TREATED / VON WILLEBRAND FACTOR

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Important safety information related to infections
When medicines are made from human blood, steps are taken to stop infections (e.g. HIV
and Hepatitis) being passed on to the patient. This includes:
• Careful selection of the blood donors
• Testing of each donation for signs of infection
• Steps in the manufacture which can kill or remove viruses
However, there is still a small chance of an infection being passed on to the patient.
This may include a new virus or infection. Therefore, every time Haemate P is used,
it is important to note the name and batch number of the medicine (found
on the carton).

PATIENT INFORMATION LEAFLET

HAEMATE® P
500 & 1000 IU
Powder and solvent for solution for injection or
infusion
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 further questions, please ask your doctor or your haemophilia nurse.
• This medicine has been prescribed for you personally and you should 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, please tell your doctor or haemophilia nurse. This includes
any side effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Haemate P is and what it is used for
2. What you need to know before you use Haemate P
3. How to use Haemate P
4. Possible side effects
5. How to store Haemate P
6. Contents of the pack and other information

3. HOW TO USE HAEMATE P
The amount of factor VIII or von Willebrand factor you need will depend on several
factors, such as your weight, the severity of your condition, the site and severity of
bleeding or the need to prevent bleeding during an operation or investigation.
Haemate P is given by injection or infusion into a vein. If you have been prescribed
Haemate P to use at home, your doctor or haemophilia centre nurse will make sure that
you are shown how to inject it and how much to use.
If you are in any doubt about injecting Haemate P, go back to your doctor or
haemophilia centre for more advice and training before attempting to treat
yourself.
Follow the directions given to you by your doctor or haemophilia nurse. You can also use
the directions below as a guide.
Directions for preparing and administering Haemate P
Wash your hands thoroughly using soap and warm water.
If necessary, warm the Haemate P powder vial and the liquid (Water for injections) vial to
room or body temperature without opening either vial. You can do this by leaving the
vials to stand at room temperature for about an hour or, if you need them quickly by
holding them in your hands for a few minutes.
DO NOT expose the vials to direct heat or stand the vials on a radiator. The vials must not
be heated above body temperature (37 ºC).
Carefully remove the protective caps from the vials and clean the exposed rubber
stoppers with the alcohol swab provided. Allow the vials to dry before opening the
Mix2Vial package, then follow the instructions given below.

1. WHAT HAEMATE P IS AND WHAT IT IS USED FOR
Haemate P is a product made from human plasma (this is the liquid part of the blood). It
contains human von Willebrand factor and human coagulation factor VIII. It is used to
prevent or stop the bleeding caused by a lack of factor VIII (haemophilia A) or von Willebrand
factor (von Willebrand disease) in your blood. Both these factors are needed for the
formation of blood clots which help bleeding to stop.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HAEMATE P
Do not use Haemate P
• If you are allergic to any of the ingredients. If you are unsure about this, ask your
doctor (see section 6).
Take special care with Haemate P
• If you experience any signs of an allergic reaction to Haemate P (for example a rash,
tight chest, wheezing or feeling dizzy), stop injecting the product immediately and
contact your doctor.
• You should visit your doctor or haemophilia treatment centre regularly to ensure that
your dose is correct. The doctor may wish to carry out some tests to make sure that
you are getting the right amount.
• If your bleeding is not being controlled with Haemate P, tell your doctor immediately.
You may have developed an inhibitor (an antibody which can cancel out the effects of
factor VIII) and your doctor may wish to carry out more tests to confirm this.
• If you have von Willebrand disease, you may be at risk of developing thrombosis (blood
clots) or embolism (when a piece of blood clot breaks loose and travels through the
bloodstream in the blood vessels), including blood clots in the lungs, particularly if you
have known risk factors. See section 4 for symptoms of thrombosis.
• Hepatitis A and B vaccination should be a consideration for patients who receive
regular/repeated treatment of human plasma-derived products.
Taking or using other medicines
There are no medicines that are known to react with Haemate P. However, if you are taking
another medicine and are concerned, please ask your doctor or haemophilia nurse.
Pregnancy, breast-feeding and fertility
If you are pregnant or planning a family soon, or if you are breast-feeding, ask your
doctor for advice before using this product.
Driving and using machines
Haemate P does not affect your ability to drive or use machines.
Important information about some of the ingredients of
Haemate P
Haemate P contains up to 70 mg sodium per 1000 IU. Please take this into account if you
are on a sodium (salt) controlled diet as you may need to cut down on the salt in your
diet.

1. Open the Mix2Vial package by peeling off the lid. Do not remove
the Mix2Vial from the blister package.

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2. Place the solvent vial on an even, clean surface and hold the vial
tight. Take the Mix2Vial together with the blister package and
push the blue adaptor end straight down through the solvent vial
stopper.

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3. Carefully remove the blister package from the Mix2Vial set by
holding at the rim and pulling vertically upwards. Make sure
that you only pull away the blister package and not the Mix2Vial
set as well.

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4. With the product vial firmly on an even surface, turn the solvent
vial with the Mix2Vial set attached upside down and push the
spike of the transparent adaptor end straight down through the
product vial stopper.
The solvent will automatically flow into the product vial.

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F4277 G28 A

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The following information is intended for healthcare professionals only
Posology
Von Willebrand Disease:
Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 0.02 IU/ml (2 %).
Levels of VWF:RCo greater than 0.6 IU/ml (60 %) and of FVIII:C greater than 0.4 IU/ml
(40 %) should be achieved.
Usually, 40 – 80 IU/kg bodyweight VWF:RCo and 20 – 40 IU/kg bodyweight FVIII:C are
recommended to achieve haemostasis.
An initial dose of 80 IU/kg VWF:RCo may be required, especially in patients with type 3
von Willebrand disease, where maintenance of adequate levels may require higher doses
than in other types of von Willebrand disease.
Prevention of haemorrhage in case of surgery or severe trauma
For prevention of excessive bleeding during or after surgery, the injection should be started
1 to 2 hours before the surgical procedure.
An appropriate dose should be re-administered every 12 – 24 hours. The dose and duration
of treatment will depend on the clinical status of the patient, the type and severity of
bleeding and both the VWF:RCo and FVIII:C levels.
When using a factor VIII-containing von Willebrand factor product, the treating physician
should be aware that continued treatment may cause an excessive rise in FVIII:C. After
24 – 48 hours of treatment, in order to avoid an uncontrolled rise in FVIII:C, reduced
doses and/or prolongation of the dose interval should be considered.
Paediatric population
Dosing in children is based on bodyweight and is therefore generally based on the same
guidelines as for adults. The frequency of administration should always be tailored to
clinical effectiveness in the individual case.
Haemophilia A
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,
which are related to the current World Health Organisation (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 IU of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal
human plasma.
On demand treatment
The calculation of the required dosage of factor VIII is based on the empirical finding that
1 IU factor VIII per kg bodyweight raises the plasma factor VIII activity by about 2% (2 IU/dl)
of normal activity.
The required dosage is determined using the following formula:
Required units = body weight (kg) x desired factor VIII rise (% or IU/dl) x 0.5.
The amount to be administered and the frequency of administration should always be
tailored to clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, the factor VIII activity should not fall
below the indicated plasma activity level (in % of normal or IU/dl) within the corresponding
period.

5. With one hand, grasp the product-side of the Mix2Vial set and
with the other hand, grasp the solvent-side and unscrew the set
carefully into two pieces (to avoid excessive build-up of foam
when dissolving the powder). Discard the solvent vial with the
blue Mix2Vial adaptor attached.
Do not worry if there are a few flakes or particles left in the water
as this can happen sometimes. They will be removed by the filter
when you draw the liquid into the syringe.
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Degree of haemorrhage/
Type of surgical
procedure

Factor VIII level
required
(% or IU/dl)

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The following table can be used to guide dosing in bleeding episodes and surgery:

6. Gently swirl the product vial with the transparent adaptor attached
until the powder is fully dissolved. Do not shake.

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

Haemorrhage

Early haemarthrosis,
muscle bleeding or
oral bleeding

20 – 40

Repeat every 12 – 24 hours
(at least 1 day) until the bleeding
episode, as indicated by pain, is
resolved or healing is achieved.

More extensive arththrosis,
muscle bleeding
or haematoma

30 – 60

Repeat infusion every 12 – 24 hours
for 3 – 4 days or more until pain and
disability are resolved.

Life-threatening
haemorrhages

60 – 100

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

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7. Draw air into an empty, sterile syringe. While the product vial is
upright, connect the syringe to the Mix2Vial´s Luer Lock fitting
and inject air into the product vial.

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Surgery

Minor including tooth
extraction
Major

30 – 60
80 – 100
(pre- and
postoperative)

Once you have made up the solution, it should be used immediately. If this is
not possible it should be used up within 8 hours.

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

Withdrawal and application

Repeat infusion every 8 – 24 hours
until adequate wound healing, then
treat for at least another 7 days to
maintain a factor VIII activity of 30 to
60 % or IU/dl.

8. Keep the syringe plunger pressed in, turn the system upside down
and draw the liquid into the syringe by pulling the plunger back
slowly.

Prophylaxis
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.
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.
Patients should be monitored for the development of factor VIII inhibitors.
Previously untreated patients
The safety and efficacy of Haemate P in previously untreated patients have not yet been
established.
Paediatric population
There are no data available from clinical studies regarding the dosage of Haemate P in
children with haemophilia A.
Method of administration
For intravenous use.
If necessary, the preparation should be warmed to room or body temperature, then
reconstituted as described in section 6.6 of the SmPC and in the Patient Information
Leaflet. Then the product should be administered slowly via the intravenous route, at a
rate comfortable for the patient. If it is not administered immediately, storage should not
exceed 8 hours at room temperature. Once the product has been transferred into a syringe,
it should be used immediately.
Where a large volume is required, infusion is an alternative option. The reconstituted
preparation should be transferred to an approved infusion system.
The injection or infusion rate should not exceed 4 ml per minute. The patient should be
observed for any immediate reaction. Should any reactions occur, which might be related
to the administration of Haemate P, the rate of infusion should be decreased or administration stopped, as appropriate. See also section 4.4 of the SmPC.
Special warnings and special precautions for use
When using a factor VIII-containing VWF product, the treating physician should be aware
that continued treatment may cause an excessive rise in FVIII:C. In patients receiving FVIIIcontaining VWF products, plasma levels of FVIII:C should be monitored to avoid sustained
excessive FVIII:C plasma levels which may increase the risk of thrombotic events, and
antithrombotic measures should be considered.
Undesirable effects
When very large or frequently repeated doses are needed, e.g. when inhibitors are present
or when pre- and post-surgical care is involved, all patients should be monitored for signs
of hypervolemia. In addition, those patients with blood groups A, B and AB should be
monitored for signs of intravascular haemolysis and/or decreasing haematocrit values.
Any unused product should be disposed of in accordance with local requirements.

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9. Once the liquid has all been transferred into the syringe, hold onto
the barrel of the syringe firmly while keeping the syringe plunger
facing down and disconnect the transparent Mix2Vial adaptor set
from the syringe.
If there are any particles in the liquid in the syringe, or
it is cloudy do not inject it as this could block your blood
vessels.
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10. Attach a suitable injection needle (or the slow injection kit) to the syringe and get rid
of all trapped air by turning the needle upwards and tapping the syringe gently so that
any air bubbles rise, then push the barrel of the syringe up gently until the liquid
begins to come out of the end of the needle. Once the product has been transferred
into a syringe, it should be used immediately.
11. Apply a tourniquet as you have been shown and find a suitable vein, clean the skin
surface with an alcohol swab and insert the needle or slow injection kit into the
vein. Make sure that no blood enters the syringe.
12. Remove the tourniquet and inject the solution slowly into the vein, keeping the needle
in place all the time. The solution should be injected at a maximum rate of
4 ml per minute.
13. If more than one vial of Haemate P is needed, leave the syringe attached to the slow
injection kit. Prepare a new vial as directed in steps 1 – 9, fill a new syringe, remove
the old syringe from the slow injection kit and repeat steps 10 – 13.
14. If no further vials are needed, remove the needle or slow injection kit plus syringe,
hold a sterile swab over the injection site for about 2 minutes with the arm stretched
out and supported, then apply a small plaster.
Any unused solution should be left in the vial or syringe. Dispose of all vials, needles,
syringes and swabs in a 'Sharps box' or as you have been told. Do not throw them
away with your household rubbish.
If you use more Haemate P than you should
No symptoms of overdose with Haemate P have been reported. However, if you
accidentally inject a large overdose, then you should tell your doctor or haemophilia centre
immediately.
In some circumstances, you may be at risk of a thrombosis (blood clot). Symptoms of a
thrombosis are listed in the side effects section.
If you forget to use Haemate P
Inject your normal dose as soon as you remember and then continue as instructed by your
doctor or haemophilia nurse.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Haemate P can cause side effects, although not everybody gets them.
Rare side effects (affect less than 1 in 1,000 people):
• Fever
Very rare side effects (affect less than 1 in 10,000 people):
• Chills, flushing, redness, swelling
• Burning and stinging around the injection/infusion site
• Itching, tingling, rash
• Headache, dizziness, feeling sick or actually being sick
• Tight chest, wheezing, faster heartbeat
• Feeling restless or feeling tired
If your side effects are severe, this could be a sign of allergic shock (anaphylaxis), so stop
your injection immediately and contact your doctor.
If you inject too much Haemate P, you may be at risk of a thrombosis (blood clot),
especially if you have von Willebrand disease. You may also be at risk if you are
overweight and/or you have ever had a thrombosis before, or if anyone in your family has
suffered with a thrombosis.
Symptoms of a thrombosis include:
• Unusual pain or swelling in your legs
• Sudden sharp pain in your chest
• Sudden difficulty breathing
• An unusual, severe or long-lasting headache
• Dizziness or fainting
Very rarely, there is a risk of thromboembolic events occurring (when a piece of blood clot
breaks loose and travels through the bloodstream in the blood vessels). This could affect
one or more important organs, such as your heart and lungs.
If you have any of these symptoms, stop your injection immediately and contact your
doctor.
If you notice that your Haemate P is less effective than usual, contact your doctor or
haemophilia centre immediately.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the UK 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 HAEMATE P
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Do not freeze. Keep the vials in the outer carton, in order to
protect from light.
Do not use Haemate P after the expiry date on the carton. Please ask your doctor or
haemophila nurse how to dispose of the medicine properly.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Haemate P contains
The active substances are:
500 or 1000 International Units (IU) human plasma coagulation factor VIII and
° 1200
or 2400 IU von Willebrand factor.
Other ingredients are:
acid
° aminoacetic
albumin
° human
citrate
° sodium
chloride
° sodium
traces of sodium hydroxide or hydrochloric acid may also be present, (used for pH
° adjustment).
The pack contains:
1 vial with powder
1 vial with 10 or 15 ml Water for Injections
Also supplied, Administration set containing:
1 filter transfer device 20/20
1 disposable 10 or 20 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Bottles of product and liquid will appear partly empty but this is normal and does not
mean that there is the wrong amount of powder or solution.
Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
This leaflet was last revised in 11/2014

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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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