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ALBUMIN DILUENT FOR RECONSTITUTION OF PHARMALGEN BEE AND WASP VENOM

Active substance(s): HUMAN ALBUMIN

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Patient Information Leaflet
2. Before you are given Pharmalgen

Pharmalgen Bee Venom
Pharmalgen® Wasp Venom
®

Please read this leaflet carefully before these
injections are given to you.
If you have any further questions, please ask your
doctor.
In
1.
2.
3.
4.
5.
6.
7.

this leaflet:
What is Pharmalgen and what is it for?
Before you are given Pharmalgen
How will you be given Pharmalgen?
Possible side effects
How should Pharmalgen be stored?
More about Pharmalgen
Further Information

1. What is Pharmalgen and what is it for?
Pharmalgen Bee Venom and Pharmalgen Wasp
Venom can be used in two ways:
For treatment
• Pharmalgen Bee Venom and Pharmalgen
Wasp Venom are treatments to reduce your
body’s reaction to bee or wasp stings. In the
rest of this leaflet, these medicines will be
called Pharmalgen.
For diagnosis
• Pharmalgen is also used to test if a person
will react too strongly to bee or wasp stings.
• No specific indication for children can be made.
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You should not be given Pharmalgen if:
• You have a disease of, or a problem with,
your immune system
• You have chronic heart or lung disease or
severe arterial hypertension or are being
treated with ß-blockers
• You are being treated with tricyclic
antidepressants or monoamine oxidase
inhibitors (MAOIs)
• You currently have cancer
• You have severe asthma (seasonal or chronic)
• You are being treated with ACE inhibitors
(medicines for heart or blood pressure)
Before you are given Pharmalgen, you
should tell your doctor if:
• You have had a test for a reaction to bee or
wasp venom
• You have ever had a bad reaction to this
injection or any medicines containing bee or
wasp venom
• You suffer from asthma
• You have recurrent or frequent infections
Pregnancy and breast-feeding
Treatment with Pharmalgen should not be
started if you are already pregnant. If you are
likely to become pregnant or you get pregnant
during your treatment, talk to your doctor for
advice. If you are breast-feeding, ask your doctor
for advice.
Take special care with Pharmalgen
Avoid alcohol, hot baths, and strenuous physical
exercise on the days you receive your injection.
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Special care should be given if children younger
than 5 years of age are treated with Pharmalgen.
Your doctor will carefully weight the risk-benefit
for the individual child. For children > 5 years of
age clinical data of efficacy are sparse, however
data on safety do not reveal a higher risk as for
adults.
Taking other medicine
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
In particular tell your doctor if you are
taking:
• Antihistamines to reduce allergic reactions
• Medicines to help you breathe
(bronchodilators)
• Medicines for travel sickness
• Medicines for heart or blood pressure
(ß-blockers and ACE inhibitors)
• Antidepressants (tricyclics and monoamine
oxidase inhibitors (MAOIs))
• Or if you are being treated with other allergens
• Or if you have recently received any vaccines
Driving
Pharmalgen is not expected to affect your ability
to drive or operate machinery.
3. How will you be given Pharmalgen?
• Your diagnosis and treatment will be carried
out by an experienced doctor.
• There are no fixed doses. All patients are
treated individually. The doctor will work
out which dose is correct for you
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• You will be looked after in hospital or clinic for
at least 60 minutes after the injections.
Diagnosis
Before treatment starts, you will have a test
using Pharmalgen to make sure that it is bee
venom or wasp venom that is responsible for
producing your allergy. This is the diagnosis. This
test will probably be a skin prick test but may be
an injection under the skin. Alternatively, your
allergy may be confirmed by testing your blood.
Treatment
Treatment of your bee or wasp venom allergy is
in two phases, the initial phase and the
maintenance phase. Pharmalgen will be given to
you as an injection under the skin. It will not be
injected into a vein.
• Initial phase
In the initial phase, the dose of Pharmalgen
is increased by small amounts until the
maximum dose suitable for you
(maintenance dose) has been reached.
The injections in the initial phase will usually
be 3-7 days apart. If necessary, your doctor
may decide to give you 2-4 injections, 30
minutes apart, once a week until the
maximum dose is reached. If you are
already in hospital, your doctor may decide
to give you up to 4 injections a day, 2 hours
apart.
• Maintenance phase
You will be given an injection containing the
maintenance dose each month for at least
three years.
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4. Possible side effects
Like all medicines, Pharmalgen can cause side
effects although not everybody gets them. If
symptoms of side effects occur they usually
occur within the first 30 minutes after the
injection, but they may occur up to 24 hours
after the injection.
Very common side effects (affecting more
than 1 person out of 10):
• A continuously spreading weal may be formed at
the site during the first 10-20 minutes after the
application of the allergen.
• Local widespread swelling and redness may
happen 6-24 hours after the application of
the allergen.
• Swelling, redness, pain, itching and local nettle
rash where the injection needle entered the
skin may appear within 30 minutes and may
last for up to 6 hours.
Common side effects (affecting more than
1 person out of 100): please tell your
doctor if long or severe
• Nettle rash, tiredness, wheezing, chest
tightness and flushing
• Headache, sneezing, coughing, itching, stuffy
and runny nose, itchy eyes, asthma and general
discomfort
Most local side effects are mild in nature and can
be treated with medication if needed. Please talk
to your doctor for advice.
Rare side effects (affecting more than 1
person out of 10,000): please get doctor’s
help straight away
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Anaphylactic reaction
In very rare cases (less than 1 in 10,000 patients)
an anaphylactic reaction (a severe allergic
reaction) may occur after skin-prick test with
active allergens, within the first minutes after
treatment.
An anaphylactic reaction is a severe reaction
throughout the body and the onset is
characterised by flushing, intense itching of the
skin (like palms of hands and soles of feet or
other areas of the body), raised rash (like a
nettle rash). In addition, symptoms of an
anaphylactic reaction may include swelling of the
lips, throat and tongue; shortness of breath;
wheezing; hoarseness; nausea; diarrhoea;
vomiting; stomach cramp; low blood pressure;
fast heart beat; disturbances of the heart rhythm
and loss of consciousness.
If this happens your doctor or health professional
will have an emergency kit available with a 'ready
for use' adrenaline syringe.
This is the reason why you are kept in hospital
or clinic for at least one hour after having had
your injection.
TELL YOUR DOCTOR/NURSE IMMEDIATELY IF
YOU FEEL ANY OF THESE CHANGES. He or she
will be able to give you the right treatment at once
to make you feel well.
If any of the side effects get serious, of if you
notice any side effects not listed in this leaflet,
please tell your doctor.
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5. How should Pharmalgen be stored
• The hospital or clinic will store Pharmalgen in
a refrigerator (2 °C - 8 °C) in the outer
carton.
6. More about Pharmalgen

The Maintenance Treatment Set contains:
• Four glass bottles, each labelled 4, which,
when diluted with Albumin Diluent give a
100 mcg/ml solution.
• Four glass bottles of 5.0 ml sterile Albumin
Diluent

What Pharmalgen contains
Pharmalgen contains an extract of specific
allergen. Pharmalgen Bee Venom contains bee
venom and Pharmalgen Wasp Venom contains
wasp venom. The allergen is the active substance
that causes the allergic reaction to either bee or
wasp stings.
Pharmalgen is dissolved in Albumin Diluent
before being injected into you. The Albumin
Diluent contains only inactive ingredients: human
serum albumin, phenol, sodium chloride and
water for injections.

Marketing Authorisation Holder and
Manufacturer:
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark

What Pharmalgen looks like and the
content of the pack
Pharmalgen is available as an Initial Treatment Set
or a Maintenance Treatment Set.

Allergy UK
Tel: 01322 619 898
www.allergyuk.org

Distributor:
ALK-Abelló Ltd
1 Manor Park, Manor Farm Road, Reading,
Berkshire, RG2 0NA
7. Further Information

This leaflet was last approved June 2010
The Initial Treatment Set contains:
• Four glass bottles containing different
amounts of Pharmalgen, labelled with a
different colour coded number (1, 2, 3 and 4)
which, when diluted with Albumin Diluent
give 0.1, 1.0, 10 and 100 mcg/ml.
• Four glass bottles of 5.0 ml sterile Albumin
Diluent

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For information in Large Print, tape, CD or
Braille, please phone 0118 903 7940

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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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