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ALPHANATE POWDER FOR INJECTION

Active substance(s): HUMAN COAGULATION FACTOR VIII

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Alphanate®

Human coagulation factor VIII and von Willebrand
factor complex

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
ALPHANATE®

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 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.

Do not use Alphanate®
• If you are allergic to human coagulation factor VIII
and von Willebrand factor complex or any of the
other ingredients of this medicine (listed in section 6).
• If you have not been fully trained how to inject
yourself by your doctor or haemophilia nurse.
If you want more detailed information then ask your
doctor.

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

Powder and solvent for solution for injection
1. WHAT ALPHANATE® IS AND WHAT IT IS USED FOR

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Alphanate® is supplied as a powder for solution for
injection containing approximately 250, 500, 1000 or
1500 IU of human coagulation factor VIII and 300, 600,
1200 or 1800 IU of human von Willebrand factor per
vial (Note IU stands for international unit, a standard
measure of activity).
Once reconstituted with the appropriate amount of
solvent (water for injections), each vial contains
approximately 50, 100 or 150 IU of FVIII/ml and 60, 120
or 180 IU VWF/ml.
Alphanate® is one of the group of medicines called
clotting factors.
Alphanate® is used for the treatment and prevention
of bleeding in patients with haemophilia A (congenital
factor VIII deficiency).
Alphanate® is used for the treatment and prevention
of bleeding (haemorrhage) or surgical bleeding in
von Willebrand disease (VWD), when desmopressin
(DDAVP) treatment alone is ineffective or contraindicated.
This product may be used in the management of
acquired factor VIII deficiency.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Alphanate®.
• Rarely you may have an anaphylactic reaction
(a sudden severe allergic reaction) such as
rash, tightness of the chest, dizziness, vertigo or
nausea, or feeling dizzy when you are standing.
If these symptoms occur, you must stop using the
product immediately and contact your doctor.
• Your doctor should perform some tests to make
sure that the dosage of Alphanate® you are
receiving is enough to achieve and maintain
appropriate factor VIII levels and thus stop any
bleeding.
• If your bleeding is not controlled with Alphanate®,
consult your doctor immediately. You may have
developed factor VIII inhibitors, these are antibodies
which block the clotting effect of factor VIII. Your
doctor will perform some tests to confirm whether
the inhibitors are present in your blood.
• During the treatment of the von Willebrand
disease, there is a chance you may develop blood
clots, particularly if you have known clinical risk
factors. Therefore, your doctor should perform
some tests to detect early signs of blood clots and
recommend the treatment if necessary.
• Patients with von Willebrand disease, especially
type 3 patients, may develop antibodies (inhibitors)
to von Willebrand factor. Your doctor may perform
more blood tests to confirm whether the inhibitors
are present in your 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 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.
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 for pregnant women (foetal 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 Alphanate® the name and batch number of
the product are recorded in order to maintain a record
of the batches used.
See also section 4.
Other medicines and Alphanate®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
No interactions of Alphanate® with other medicines
are known.
Do not mix Alphanate® with any other medicines that
you receive by injection.
Pregnancy and breast-feeding
Based on the rare occurrence of haemophilia A in
women, experience regarding the use of FVIII/VWF
complex during pregnancy and breast-feeding is not
available.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Alphanate® has little or none effect on your ability to
drive and use machines.
Sodium content
The residual content of sodium in Alphanate®, arising
from the manufacturing process, does not exceed
23 mg (1 mmol) per vial. This is equivalent to 1.15%
of the recommended maximum daily intake of sodium
for an adult. However, depending on the body weight of
the patient and the posology, the patient may receive
more than one vial.

3. HOW TO USE ALPHANATE®
Reconstitute the product as described at the end
of this leaflet (please see pictograms on the back
of the leaflet). The product must be given by
intravenous route. The administration rate should
be 3 ml/min and never more than 10 ml/min to
avoid undesirable side effects. Inject Alphanate®
immediately after reconstitution.
The amount of Alphanate® you should use depends
on many factors, such as your weight, your clinical
status and the type and severity of bleeding. Your
doctor will calculate the dose, the frequency and
the intervals of administration of Alphanate® in
order to reach the necessary level of factor VIII or
von Willebrand factor in your blood.
Your doctor will tell you the duration of your
treatment with Alphanate®.
You will be given full training before using
Alphanate® without the hospital supervision.
Please refer to all your training materials or contact
your local haemophilia centre for more information.
You should not self-administer Alphanate® alone:
always have a responsible adult present.
Use in children and adolescents
There are insufficient data from clinical trials to
recommend the use of Alphanate® in children less
than 6 years of age for the authorised indications.
If you use more Alphanate® than you should
No cases of overdose with Alphanate® have been
reported. However, if you have used Alphanate®
more than required, consult your doctor or
pharmacist immediately.
If you forget to use Alphanate®
Proceed immediately with the following dose and
continue at regular intervals as directed by your
doctor. Do not take a double dose to make up for a
forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
On rare occasions, you may have some of the
following side effects after the administration
of Alphanate®. Please contact your doctor
immediately if you experience:
• itching, local reactions at the injection site (e.g.
burning and transitory reddening)

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• allergic reactions (e.g. tightness of the chest/
feeling unwell, dizziness, nausea and slight
drop of blood pressure than can make you feel
dizzy when you are standing)
• fever
• faster heart beat (tachycardia)
Occasionally an anaphylactic shock may occur. If
you observe any of the following symptoms during
the injection/perfusion, interrupt the injection/
perfusion and contact your doctor immediately:
• tightness of the chest/feeling unwell
• dizziness
• slight hypotension (slight drop of blood pressure
with dizziness when you are standing)
• nausea
Allergic reactions to the components of the product
cannot be totally excluded. The formation of
neutralising antibodies of factor VIII (inhibitors)
is a well-known complication in the treatment of
patients with haemophilia A. Study results show
that first time users of factor VIII are mainly
affected. You will be carefully monitored for the
development of these inhibitors.
There is a chance of blood clots, particularly if you
have known clinical risk factors.
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 Yellow Card
Scheme, Website: https://yellowcard.mhra.gov.uk.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE ALPHANATE®
Keep this medicine out of the sight and reach of
children.
Do not store above 30 °C. Do not freeze. Protect
from light.
Do not use this medicine after expiry date which is
stated on the vial label and carton after EXP.
Do not use this medicine if you notice the solution
is cloudy or has deposits. Generally the solution
is clear or slightly opalescent. If the solution is
discoloured or cloudy discard it.
Alphanate® should be administered immediately
after reconstitution
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 throw
away medicines you no longer use. These measures
will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Alphanate® contains
The active substance is human coagulation factor VIII
and von Willebrand factor complex.
Alphanate® is presented as powder for solution for
injection containing approximately 250, 500, 1000 or
1500 IU human coagulation FVIII and 300, 600, 1200
or 1800 IU of human von Willebrand factor per vial.
The product is reconstituted with 5 ml of water for
injections for the presentations of 250 and 500 IU or
10 ml of water for injections for the presentations of
1000 and 1500 IU.
The other ingredients are albumin, histidine and
arginine.
What Alphanate® looks like and contents of the pack
Vial containing white or pale yellow powder and
syringe with water for injections (solvent).
Presentations:
Alphanate® 250 IU (250 IU/5 ml)
Alphanate® 500 IU (500 IU/5 ml)
Alphanate® 1000 IU (1000 IU/10 ml)
Alphanate® 1500 IU (1500 IU/10 ml) PL 12930/0015
Water for Injections
PL 4447/0016
Pack size: 1 lyophilised vial, 1 syringe pre-filled with
solvent and accessories (vial adaptor, filter, 2 alcohol
swabs and butterfly needle).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer:
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - SPAIN

Instructions for use/handling
Follow these instructions unless otherwise indicated
by your doctor.
Left-over product must never be kept for later use, nor
stored in a refrigerator.
To prepare the solution:
1. Warm the vial and syringe but not above 30 ºC.
2. Attach plunger to syringe containing solvent.
3. Remove filter from packaging. Remove cap from
syringe tip and attach syringe to filter.
4. Remove vial adaptor from packaging and attach to
syringe and filter.
5. Remove cap from vial and wipe stopper with
swabs provided.
6. Pierce vial stopper with adaptor needle.
7. Transfer all solvent from syringe to vial.
8. Gently shake vial until all product is dissolved.
As with other parenteral solutions, do not use if
product is not properly dissolved or particles are
visible.
9. Briefly separate the syringe/filter from vial/
adaptor, to release the vacuum.
10. Turn the vial upside down and draw the solution
into the syringe.
11. Prepare injection site, separate syringe and inject
product using the butterfly needle provided.
Injection rate should be 3 ml/min into a vein and
never more than 10 ml/min to avoid vasomotor
reactions.
Do not re-use administration sets.

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Distributed by:
Grifols UK Ltd.
Byron House
Cambridge Business Park
Cambridge CB4 0WZ

This leaflet was last revised in April 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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