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PHARMALGEN BEE VENOM POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): BEE VENOM

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1046345 (022014)_Pil_UK_PH patient_draft140227_PH UK 1046345 (022014) 27-02-2014 07:31 Side 1

1046345 (02/2014)

Package leaflet: Information for the user

Pharmalgen® Bee Venom
Pharmalgen® Wasp Venom
0.1-100μg/ml and 100μg/ml
powder and solvent for solution for injection
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 or nurse.
- If you get any side effects, talk to your doctor
or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Pharmalgen is and what it is used for
2. What you need to know before you use
Pharmalgen
3. How to use Pharmalgen
4. Possible side effects
5. How to store Pharmalgen
6. Contents of the pack and other information
1. What Pharmalgen is and what it is used 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.
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Draft 1 (27.02.2014) ALK-Madrid

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.
2. What you need to know before you use
Pharmalgen
Do not use Pharmalgen if:
• If you are allergic to any of the ingredients of
this medicine apart from the active substance
(listed in section 6)
• 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)
Warnings and precautions
Talk to your doctor or nurse before using
Pharmalgen 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

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Other medicines and Pharmalgen
Tell your doctor if you are using, have recently
used or might use any other medicines.

If you are suffering from mastocytosis you may
expect less efficacy compared with general insect
venom allergic population.

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
(beta-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 and using machines
Pharmalgen is not expected to affect your ability
to drive or operate machinery.

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.
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.
If levels of tryptase in your blood are increased
and/or you are suffering from mastocytosis, the
risk of side effects may be increased.
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3. How to use 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
• You will be looked after in hospital or clinic for
at least 60 minutes after the injections.

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.
4. Possible side effects

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.

Like all medicines, this medicine 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.

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

• 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.

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Very common side effects (affecting more
than 1 person out of 10):

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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

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.

Most local side effects are mild in nature and can
be treated with medication if needed. Please talk
to your doctor for advice.

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.

Rare side effects (affecting more than 1
person out of 10,000): please get doctor’s
help straight away

If any of the side effects get serious, of if you
notice any side effects not listed in this leaflet,
please tell your doctor.

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.
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Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. You can also report side
effects directly via the MHRA Yellow Card Scheme
at 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 Pharmalgen
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the bottle after EXP. The
expiry date refers to the last day of that month.
The hospital or clinic will store Pharmalgen for
you in the refrigerator (2°C - 8°C) in the outer
carton.
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6. Contents of the pack and other
information
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.
What Pharmalgen looks like and contents
of the pack
Pharmalgen is available as an Initial Treatment Set
or a Maintenance Treatment Set.

• Four glass bottles of 5.0 ml sterile Albumin
Diluent
Marketing Authorisation Holder and
Manufacturer:
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark
Distributor:
ALK-Abelló Ltd
1 Manor Park,
Manor Farm Road,
Reading, Berkshire.
RG2 0NA.
This leaflet was last revised in February 2014
For information in Large Print, tape, CD or
Braille, please phone 0118 903 7940

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