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PHARMALGEN BEE VENOM POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): BEE VENOM / BEE VENOM

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1046345 (042017)_Pil_UK_PH patient_170425_PH UK 1046345 (022014) 25-04-2017 10:50 Side 1

1046345 (04/2017)

Package leaflet: Information for the user

Pharmalgen® Bee Venom
Pharmalgen® Wasp Venom
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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25.04.2017 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

2

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.

maintenance phase. Pharmalgen will be given to
you as an injection under the skin. It will not be
injected into a vein.

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.

• 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.

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.

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.
Diagnosis
Pharmalgen is dissolved in Albumin Diluent by
the healthcare professional before the product is
ready to be used. Healthcare professionals should
see section at the end of the technical
information leaflet for detailed instruction on
how to dissolve and dilute Pharmalgen.

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.

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.

If levels of tryptase in your blood are increased
and/or you are suffering from mastocytosis, the
risk of side effects may be increased.

Treatment
Treatment of your bee or wasp venom allergy is
in two phases, the initial phase and the

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4

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
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.
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.
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• 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.

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.

Common side effects (affecting more than
1 person out of 100): please tell your
doctor if long or severe

If this happens your doctor or health professional
will have an emergency kit available with a 'ready
for use' adrenaline syringe.

• Nettle rash, tiredness, wheezing, chest
tightness and flushing
• Headache, sneezing, coughing, itching, stuffy
and runny nose, itchy eyes, asthma and general
discomfort

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).
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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.

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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.
Shelf life after reconstitution and dilution with
Albumin Diluent:
Concentration
(µg venom/ml)

Shelf life

100
All dilutions <100 µg/ml

6 months
A maximum of 24
hours after first
dilution

The hospital or clinic will store Pharmalgen for
you in the refrigerator (2°C - 8°C) in the outer
carton.
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.
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What Pharmalgen looks like and contents
of the pack
Pharmalgen is available in a Treatment Set
containing: four glass bottles, which when
diluted with Albumin Diluent give a 100 µg/ml
solution and 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 April 2017
For information in Large Print, tape, CD or
Braille, please phone 0118 903 7940

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Technical Information Leaflet
This leaflet contains important information for
the prescribing doctor about Pharmalgen Bee
Venom and Pharmalgen Wasp Venom.

Pharmalgen®
Bee Venom
Pharmalgen®
Wasp Venom

In this leaflet:
1. Declaration
2. Indication
3. Posology and Method of Administration
4. Contraindications
5. Special Warnings and Precautions for use
6. Interactions with Other Medical Products
7. Pregnancy and Lactation
8. Effects on the Ability to Drive and Use
Machines
9. Undesirable Effects
10. Shelf life and Storage
11. Packages
12. Marketing Authorisation Holder and
Distributor
The patient should be clearly informed about
the benefits and risks of the treatment, before
treatment with Pharmalgen Bee Venom or
Pharmalgen Wasp Venom is initiated. In the
rest of this leaflet, these medicines will be
referred to as Pharmalgen.

1. Declaration
Pharmalgen is a powder and solvent for
solution for injection.
The active ingredient is freeze-dried
Apis mellifera (Honey Bee venom) or
Vespula spp. (Wasp venom) which is to be
reconstituted with Albumin Diluent before
use. For instructions on reconstitution and
dilution of the product before administration,
see the end of this leaflet.
Each vial of Pharmalgen Venom contains
120 µg of raw freeze-dried venom.
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25.04.2017ALK Madrid

After reconstitution with 1.2 ml Albumin
Diluent, the vials contain 100 µg venom/ml.
Only reconstitute the freeze-dried substance
required.
Series of 10-fold dilutions should be prepared
from the reconstituted solution.
Pharmalgen must not be mixed with other
medicinal products except those mentioned
above.
Excipients
Powder for solution for injection:
Mannitol
Human serum albumin
This medical product contains less than 1
mmol sodium (23mg) per dose, i.e. essentially
‘sodium free’.
Albumin Diluent:
Human serum albumin
Sodium chloride
Phenol
Water for injection

for extremely sensitive patients, testing with a
lower concentration (e.g. 1 or 10 µg venom/ml)
is advisable. For instructions on reconstitution
and dilution of the product before administration, see the end of this leaflet.
Alternatively, an end-point titration test can be
used to determine individual starting
concentrations for specific immunotherapy.
The end-point titration test is performed using
concentrations of venom from 0.01 µg
venom/ml up to 100 µg venom/ml if necessary.
If a positive reaction is observed at 0.01 µg
venom/ml, retesting must be performed using a
lower concentration. The lowest concentration
resulting in a positive reaction is used as the
end-point.
The reaction is read after 15-20 minutes.
A reaction is considered positive when a weal
with a diameter of more than 3 mm is observed.
Albumin Diluent should be used for dilution
and as control.
Intracutaneous Test:
The intracutaneous test is 100 – 1000 times
more sensitive than the skin prick test.

2. Indication
Pharmalgen Bee Venom and Pharmalgen Wasp
Venom are indicated for diagnosis and treatment
of IgE-mediated allergy to bee or wasp allergy,
respectively.
No specific indication for children can be made.

3. Posology and Method of
Administration
Diagnosis
Diagnosing allergy to bee or wasp venom using
Pharmalgen should be carried out using either
a skin prick test or an intracutaneous test.
Skin Prick Test:
A concentration of 100 µg venom/ml is recommended for use in a skin prick test. However,
2

The intracutaneous test should always be
performed as an end-point titration test. It is
recommended to start with a concentration of
0.0001 µg venom/ml and increase the concentration stepwise by a factor ten every 20 minutes until a positive reaction is observed. If a
positive reaction is observed at 0.0001 µg
venom/ml, retesting must be performed using a
lower concentration. The lowest concentration
causing a positive reaction is taken as the endpoint.
Concentrations of ≥ 1 µg venom/ml are not
recommended for the intracutaneous test as
these may cause unspecific reactions.
The reaction is read after 15 – 20 minutes. A
reaction is considered positive if a weal with a
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diameter of more than 5 mm and with
erythema is observed.
Albumin Diluent should be used for dilution
and as control.
Treatment
IgE-mediated allergy to bee or wasp venom
must be confirmed by case history and by in
vivo and/or in vitro diagnosis prior to initiating
treatment with Pharmalgen Bee Venom or
Pharmalgen Wasp Venom, respectively.
Treatment with Pharmalgen must be performed using subcutaneous injections. Intravenous
administration must be avoided due to an increased risk of potentially fatal anaphylactic reactions.
The dosage of Pharmalgen must be individually
adjusted. The dosage should depend on the patient's general condition, the allergenic anamnesis and the patient's sensitivity to the specific
allergen used.
The patient’s predisposition for an allergic reaction may be reduced by prophylactic treatment
with antihistamines. However, care should be
taken as the use of antihistamines is likely to
mask initial warning signs of anaphylaxis, e.g.
rash and pruritus.
Treatment with Pharmalgen is in two phases,
the Initial Phase and the Maintenance Phase.
Initial Phase:
In the Initial Phase, the dose of Pharmalgen is
increased stepwise until the maximum tolerated (maintenance dose) has been reached.
The initial dose is defined as 0.1 ml of the concentration which is 1000 times lower than the
end-point concentration obtained in the skin
prick test and 10 times lower than the endpoint concentration obtained in the intracutaneous test.
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For every further injection, the dose should be
increased by a factor of ten until a final concentration of 0.01 µg venom/ml has been reached.
From this point, further injections should be
given according to recommendations shown in
Table I, II or III.
Three dosage schedules intended as general
guidelines in establishing a maintenance dose
are shown in the tables below.
Each dose must be adapted to the individual
patient’s reactivity and should only be increased if the previous injection was well tolerated.
In all other cases, including interruptions in
therapy (infections, vaccinations, holidays, etc.),
the dose must be reduced accordingly.
Table Ia: Conventional Dosage Schedule
One injection every 3-7 days
Week Concentration Volume Dose
No. (µg venom/ml) (ml)
(µg venom/
injection)
1
0.1
0.1
0.01*
2
1
0.1
0.1
3
10
0.1
1
4
10
0.5
5**
5
100
0.1
10**
6
100
0.2
20**
7
100
0.3
30**
8
100
0.4
40**
9
100
0.5
50**
10
100
0.6
60**
11
100
0.8
80**
12
100
1.0
100**
*

Dose may be lower, depending on the
patient's sensitivity.
** To reduce the risk of secondary reactions,
each dose of 5-100 µg/ml venom may be
divided into halves and given as 2
injections with an interval of 30 minutes.

Table Ib:
Recommended dose reduction if an interval
between 2 injections has been exceeded while
following the Conventional Dosage Schedule.
Exceeding of
interval
> 1 - 2 weeks
> 2 - 3 weeks
> 3 - 4 weeks
> 4 weeks

Recommended dose
reduction
Repeat the last
administered dose
Reduce dose to 1/2 of
the last dose
Reduce dose to 1/10
of the last dose
Re-initiate treatment
from baseline

Table II: Modified Rush (Clustered)
Dosage Schedule
The patient is given 2 - 4 injections per week
at intervals of 30 minutes. If necessary the
treatment period may be extended up to 2
weeks.
Week Concentration Volume
No. (µg venom/ml) (ml)

1
2
3
4
5
6
7

0.1
1
1
10
10
10
100
100
100
100
100
100
100
100
100
100

0.1
0.1
1.0
0.3
0.25
0.25
0.05
0.05
0.1
0.1
0.2
0.2
0.3
0.3
0.5
0.5

Dose
(µg venom/
injection)
0.01*
0.1
1.0
3.0
2.5
2.5
5
5
10
10
20
20
30
30
50
50

* Dose may be lower depending on the
patient's sensitivity.
5

6

Table III: Rush Dosage Schedule
The patient is given an injection every 2 hours
with a maximum of 4 injections per day. The
patient must be hospitalised.
Concentration Volume
(µg venom/ml) (ml)

Dose
(µg venom/
injection)

0.1
0.1
0.1
1
1
1
1
10
10
10
10
100
100
100
100
100
100
100
100
100
100

0.01*
0.02
0.04
0.05
0.1
0.2
0.4
0.5
1.0
2.0
4.0
5.0
10
20
30
40
50
60
80
90
100

0.1
0.2
0.4
0.05
0.1
0.2
0.4
0.05
0.1
0.2
0.4
0.05
0.1
0.2
0.3
0.4
0.5
0.6
0.8
0.9
1.0

* Dose may be lower depending on the
patient's sensitivity.
Maintenance Phase:
The recommended concentration for the
maintenance dose is 100 µg/ml venom
administered in a volume of 1 ml. However, the
strength of the maintenance dose depends on
the patient’s sensitivity toward the allergen
and should be determined individually on the
basis of the patient's response during the
Initial Phase.
If allergic reactions are observed after bee or
wasp stings in patients who have achieved the
maximum dose of 100 µg Pharmalgen Bee
Venom or Pharmalgen Wasp Venom,
7

respectively, the dose can be cautiously
increased up to 200 µg.
When the maintenance dose has been
attained, the interval between the injections is
increased stepwise to two, three and four
weeks. The maintenance dose is then
administered every four weeks for a period of
at least three years.
Table IV: Dose Reduction for
Maintenance Phase Dosage Schedule
Recommended dose reduction if an interval
between two injections has been exceeded
while following the Maintenance Phase.
Exceeding of
interval

Recommended
dose reduction

> 4 – 6 weeks

Reduce dose to 3/4
of last dose
Reduce dose to 1/2
of last dose
Reduce dose to 1/4
of last dose
Re-initiate treatment
from baseline

> 6 - 8 weeks
> 8 - 10 weeks
> 10 weeks

Dose reduction when systemic
reactions are observed
If a severe, systemic reaction occurs after
injection, the treatment with Pharmalgen
should only be continued after careful
consideration. If treatment is continued, it
may be considered to reduce the following
dose to 10% of the dose provoking the
reaction.
Table V: Dose reduction when large
injection site reactions are observed
If an injection site reaction with a diameter of
8 cm or more for adults (5 cm or more for
children) occurs and is present for more than 6
hours, the subsequent dose should be reduced
according to the table below.
8

Maximum diameter
of swelling
Children
Adults

Recommended
dose reduction

< 5 cm

< 8 cm

5-7 cm

8-12 cm

Continue upward
titration according to
up-dosing schedule
Repeat dose last given

7-12 cm 12-20 cm

Reduce dose to dose
given time before last

12-17 cm > 20 cm

Reduce dose to dose
given 2 times before
last
Reduce dose to dose
given 3 times before
last

>17 cm

Concomitant treatment of more than
one allergy
Pharmalgen venom extracts must not be mixed.
Patients who are allergic to more than one
type of venom should initiate treatment with
one type of venom first. When the maintenance
dose has been attained, treatment with the
other type of venom may be initiated. The
maintenance injections of the two types of
venom should be given with an interval of
2 - 3 days.

4. Contraindications
Pharmalgen is contraindicated in patients:
• allergic to any of the ingredients of this
medicine apart from the active substance
• with immune pathologic conditions such
as immune complex and
immunodeficiency diseases
• with diseases or conditions preventing
the treatment of possible anaphylactic
reactions, e.g. chronic heart and lung
diseases, severe arterial hypertension and
treatment with ß-blockers
• treated with tricyclic antidepressants and
monoamine oxidase inhibitors (MAOIs), as the
effects of adrenaline, used in case of
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anaphylaxis, may be potentiated (with possible
fatal consequences)
• with malignancy
• with severe chronic or severe seasonal
asthma (FEV1 consistently under 70% of
predicted value after adequate pharmacologic
treatment)
• treated with ACE inhibitors

5. Special Warnings and
Precautions for Use
Treatment with Pharmalgen should be
administered under supervision of a doctor
experienced in specific immunotherapy.
Special care should be given if children younger
than 5 years of age are treated with Pharmalgen.
The physician must carefully weight the riskbenefit 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 the patient's blood are
increased and/or the patient is suffering from
mastocytosis, the risk of side effects may be
increased.
If the patient is suffering from mastocytosis the
patient may expect less efficacy compared with
the general insect venom allergic population.
Due to the risk of potentially fatal anaphylactic
reactions, treatment with Pharmalgen must be
carried out in hospitals or clinics where
facilities for cardiopulmonary resuscitation are
immediately available for use by adequately
trained personnel.
According to national guidelines the patients
must be observed for 60 minutes after having
received an injection with Pharmalgen. If
symptoms of an immediate systematic reaction
(e.g. generalised urticaria, angioedema or severe
asthma) are observed within this period,
symptomatic treatment should be initiated.
If treatment with Pharmalgen in the Initial
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Phase is performed according to the Rushed
Dosage Schedule, the patient must be
hospitalised.
Concomitant treatment with symptomatic
anti-allergy medications, e.g. antihistamines,
corticosteroids and mast cell stabilisers may
increase the patient’s tolerance level towards
the allergen injections.
Treatment precautions to be taken:
• The patient’s lung function should be evaluated
before treatment with Pharmalgen is initiated
• Patients should be instructed to avoid
strenuous physical exercise, hot baths and
alcohol on the day of injection
• Any allergic reactions following previous
treatment with Pharmalgen should be
documented and dosage should be evaluated
• The patient’s tolerance of Pharmalgen may
change if other anti-allergy medication is
altered
• Prior to each injection check for cloudiness
or any indication of contamination,
particularly in vials that have already been
opened
Adjustment or postponement of dosage is
required if:
• The patient has fever or shows other clinical
signs of acute or chronic infection
• The patient has experienced allergic
symptoms within the last 3-4 days before
treatment with Pharmalgen
• The patient shows reduced lung function
(peak flow or FEV1 ≤ 70% of expected value)
• The patient has experienced local or
systemic reactions during previous treatment
with Pharmalgen
• Atopic dermatitis has become exacerbated
• Other vaccinations have been given in the
week before treatment with Pharmalgen

the response to insect venom, resulting in
potentially life threatening allergic reactions to
insect stings or venom immunotherapy.
Temporary discontinuation of ACE inhibitor
treatment (based on the half-life of the ACE
inhibitor in question) would avoid this potential
risk. However, the risk of discontinuing treatment with an ACE inhibitor should be carefully
balanced against the benefit of the allergy
immunotherapy in patients with bee or wasp
venom induced systemic reactions.
Antihistamines and bronchodilators may
increase tolerance. The patient must be consistent in his use of these in the 24 hours before
each injection.
Other vaccines should not be given within 7 days
before or after an injection.
In rare cases patients treated with allergenspecific immunotherapy (including bee venom
and wasp venom) experience systemic allergic
reactions including anaphylactic reactions. The
choice of treatment for anaphylactic reactions
is adrenaline.
ß-blockers interact with adrenaline and the use
of ß-blockers is therefore preventing the
treatment of possible anaphylactic reactions.
Concomitant use of bee venom/wasp venom
and ß-blockers is contraindicated.
Tricyclic antidepressants and monoamine oxidase
inhibitors (MAOIs) potentiate adrenaline and
increase the risk of cardiac arrhythmias (with
possible fatal consequence) preventing treatment
of possible anaphylactic reactions. Concomitant
use of bee venom/wasp venom and tricyclic
antidepressants and monoamine oxidase
inhibitors (MAOIs) are contraindicated.

Treatment should not be initiated during
pregnancy.
Lactation:
No clinical data is available on the use of
Pharmalgen during lactation.
8. Effects on the Ability to Drive and
Use Machines
Delayed general reactions are extremely rare,
and the reactions are occurring shortly after
injection. Pharmalgen is therefore not presumed
to influence on the ability to drive or use
machines.
9. Undesirable Effects
Adverse reactions in connection with
Pharmalgen treatment are generally due to an
immunological reaction (local and/or systemic)
to the allergen. Symptoms of an early reaction
appear within the first 30 minutes after
injection. Symptoms of a delayed reaction may
appear within 24 hours after injection.
Very commonly reported adverse reactions in
patients treated with Pharmalgen were local
reactions at the injection site.
Table VI: Adverse reactions listed
according to frequency
Adverse reactions are divided into groups
according to the MedDRA-convention frequencies: Very common (≥1/10), common (≥1/100
to <1/10), uncommon (≥1/1,000 to ≤1/100),
rare (≥1/10,000 to ≤1/1,000), very rare
(≤1/10,000), Frequencies are based on clinical
trials with immunotherapy in general. Not
known means that the frequency cannot be
estimated from the available data and is based
on post marketing experience.

See text below for details of reactions and symptoms.
System Organ Class
Immune system disorders
Nervous system
disorders
Eye disorders
Ear and labyrinth
disorders
Cardiac disorders
Vascular disorders
Respiratory, thoracic and
mediastinal disorders

Gastrointestinal disorders

Skin and subcutaneous
tissue disorders
Musculoskeletal and
connective tissue
disorders
General disorders and
administration site conditions

In rare cases ACE inhibitors may exacerbate
11

Pregnancy:
The risk to the mother and foetus of an
anaphylactic reaction must be considered.
12

Adverse Drug Reaction

Uncommon
Rare
Very common
Not known
Common
Not known
Not known

Anaphylactic reaction
Anaphylactic shock
Headache
Dizziness, paraesthesia
Conjunctivitis
Eyelid oedema
Vertigo

Not known
Common
Not known
Common
Not known

Not known
Common
Not known
Uncommon
Not known

Palpitations, tachycardia, cyanosis
Flushing
Hypotension, pallor
Wheezing, cough, dyspnoea
Asthma, nasal congestion, allergic
rhinitis, sneezing, bronchospasms,
throat irritation, throat tightness
Diarrhoea, vomiting, nausea,
dyspepsia
Abdominal pain
Urticaria, pruritus, rash
Angioedema, erythema
Back pain
Joint swelling, arthralgia

Very common

Injection site swelling

Common

Injection site pruritus, injection site
urticaria, discomfort, fatigue
Pruritis, chest discomfort, chills,
injections site erythema, injection site
pain, sensation of foreign body

Common

Not known

7. Pregnancy and Lactation

6. Interaction with Other Medical
Products

Frequency

13

14

15

Local reactions
Local reactions are reactions occurring at the
injection site and include injection site swelling,
redness, pain, itching, discolouration and
haematoma. These symptoms usually appear
within 30 minutes after the injection and may
persist up to 6 hours after the injection. More
generalised pruritus may also occur.
For local reactions symptomatic medication
e.g. antihistamines should be considered.
Systemic reactions
Systemic reactions are any symptoms from
organs distant from location of injection.
Systemic reactions can vary from allergic rhinitis
to an anaphylactic shock. Treatment of a severe
systemic reaction must be initiated immediately.
Common early symptoms are generalised
urticaria, fatigue, wheezing, chest tightness and
flushing. Other early reactions are rhinitis,
blocked nose, coughing, sneezing, conjunctivitis
and asthma.
These reactions may also appear as late
reactions. Headache, itching and general
discomfort are other late reactions.
Angioedema, bronchospasm and swelling of
tongue or lips are rare systemic reactions.
Mild to moderate systemic reactions can be
effectively treated with symptomatic medication,
e.g. antihistamines.
In case of large local reactions and systemic
reactions an evaluation of the treatment must
be performed (see section 3).
For patients with severe adverse reactions,
please refer to Table Ib and Table IV.
Anaphylaxis
In rare cases patients may develop symptoms of
anaphylaxis within a few minutes after the injection. The onset of this reaction is characterised
by flushing, intensive itching of the skin (e.g.
palms of hands and soles of feet or other areas
of the body, and raised rash (like a nettle rash).
Sense of heat, general discomfort and
agitation/anxiety may also occur.
16

In addition, symptoms of anaphylaxis may include
swelling of the lips, throat, and tongue (may
occur without having breathing difficulties or
bronchospasms), and shortness of breath or
bronchial obstruction followed by pulmonary
oedema. Symptoms of the upper respiratory
tract may include sneezing, rhinitis and larynx
oedema leading to changes of the voice and
stridor. Gastrointestinal symptoms may include
nausea, abdominal pain and cramps, vomiting and
diarrhoea.
The symptoms may result in cardiovascular
symptoms such as hypotension, tachycardia,
arrhythmias, ventricular flutter and in severe
cases shock and cardiac arrest. Potential symptoms from the central nervous system include
change of consciousness, which could result in
fainting and coma.
Anaphylaxis demands prompt initiation of
anaphylactic treatment including adrenaline.
Treatment of an anaphylactic reaction must be
initiated immediately.

10. Shelf Life and Storage
The expiration period for Pharmalgen is 5 years
from the date of manufacture.
Shelf life after reconstitution and dilution with
Albumin Diluent:
Concentration
(µg venom/ml)

Shelf life

100
All dilutions <100 µg/ml

6 months
A maximum of 24
hours after first
dilution

Pharmalgen vials should be kept in the outer
carton. Store in a refrigerator (2°C – 8°C).
Do not freeze.

11. Packages
Pharmalgen is available in a Treatment Set containing four glass bottles, which when reconstituted
with Albumin Diluent give a 100 µg/ml solution
and four glass bottles of 5.0 ml sterile Albumin
Diluent
17

12. Marketing Authorisation
Holder and Distributor
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

Dilution series:
1. 10 µg/ml (1:10): 0.55 ml of the
100 µg/ml + 5 ml Albumin Diluent
2. 1 µg/ml (1:100): 0.55 ml of the
10 µg/ml + 5 ml Albumin Diluent
3. 0.1 µg/ml (1:1000): 0.55 ml of the
1 µg/ml + 5 ml Albumin Diluent
Further dilutions can be prepared using the
same method (see figure below).

0.55 ml

This leaflet was last revised in April 2017
----------------------------------------------------------

0.55 ml

0.55 ml

The following information is intended for
healthcare professionals only:
Before use the product must be reconstituted
with Albumin diluent as described below.
Reconstitution of powder:
1. Extract 1.2 ml albumin diluent in a
disposable syringe.
2. Carefully inject 1.2 ml albumin diluent into
the vial with the freeze-dried extract.
3. Carefully turn the vial over 10-20 times;
check that all the extract has dissolved. It
is now ready for use.
After reconstitution the solution contains
100 microgram/ml of insect venom. The date
of the reconstitution and the expiry date
must be noted on the label of the vial.
Lower concentrations should be obtained by
diluting the solution. Use Albumin diluent for
dilution. To avoid confusion, the vials must be
labelled before dilution (minimum information:
allergen, concentration, date of dilution and
expiry date (see section 10)).

18

100 μg/ml

freeze-dried
extract +
1.2 ml
Albumin
Diluent

1:10
10 μg/ml

1:100
1 μg/ml

5.0 ml
Albumin
Diluent
+ 0.55 ml
of 100µg/ml

5.0 ml
Albumin
Diluent
+ 0.55 ml
of 10µg/ml

1:1000
0.1 μg/ml

5.0 ml
Albumin
Diluent
+0.55 ml
of 1µg/ml

Please note! Do not use the same sterile
syringe to transfer different concentrations.
Use a brand new sterile syringe for each
dilution stage. To avoid confusion, the vials
must be labelled before dilution (minimum
information: allergen, concentration, date of
dilution and expiry date (see section 10)).

19

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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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