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POLLINEX TREES EXTENSION COURSE 2000 SU/0.5ML SUSPENSION FOR INJECTION

Active substance(s): 3 TREE MIX GLUTERALDEHYDE MODIFIED / 3 TREE MIX GLUTERALDEHYDE MODIFIED / 3 TREE MIX GLUTERALDEHYDE MODIFIED

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
POLLINEX Trees Extension Course, 2000 Standardised Units (SU)/0.5ml,
suspension for injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
POLLINEX Trees Extension Course comprises of a series of 3 pre-filled
syringes or 1 pre-filled vial in the following concentrations:
Vial/Syringe
No./Colour

Concentration (Standardised Units (SU))/0.5ml)

3 Red

2000

POLLINEX Trees Extension Course contains equal proportions of 3
selectively purified allergen extracts of pollen from the following trees:
Birch

(Betula Spp.)

Alder

(Alnus Spp.)

Hazel

(Corylus Spp.)

The allergens have been converted into allergoids by treatment with
glutaraldehyde and are adsorbed onto L-tyrosine. The allergen extracts are
characterised and standardised through immunological and biochemical
methods to ensure batch-to-batch consistent allergen content and allergenic
potency. Major allergens are measured in selected extracts. Standardisation is
reflected by the assignment of Standardised Units (SU).
For the full list of excipients see section 6.1.

3

PHARMACEUTICAL FORM
Suspension for injection
A white opaque suspension

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of seasonal allergic hay fever due to tree pollen in adults,
adolescents and children from the age of 6 who have failed to respond
adequately to anti-allergy drugs.
The diagnosis should be based on the careful consideration of the patient’s
history and allergy tests, preferably skin tests.
4.2

Posology and method of administration
Posology
POLLINEX Trees Extension Course is presented in one 3 ml multi-dose vial or three
unit dose syringes.
Each vial/syringe is prefilled with 1.5ml/0.5ml of vaccine in graded concentrations as
follows:
Vial/Syringe No. and Colour
Vial/Syringe No. 3 (Red)

Recommended dosage
2000 SU – 0.5ml

The Extension Course consists of three injections of the maximum dose of 2000
SU/0.5ml. (If the maximum dose is not tolerated, treatment can take place at a lower
dose). The first injection should be given about 14 days after the last injection of
POLLINEX Trees. Subsequent injections should then be given at intervals of 2-4
weeks. If the season is imminent, the interval can be reduced to 1 week.
The maximum dose of 0.5ml must not be exceeded.
The course should be completed before the onset of the tree pollen season.
Do not use during the tree pollen season.
POLLINEX Trees Extension Course should be given after POLLINEX Trees (PL
17087/0007) for continued clinical improvement.
It is recommended that the allergy vaccine should be given in each of three successive
years.
Paediatric population
For children from the age of 6 years and adolescents, the same posology regime as
adults is recommended.
POLLINEX Trees Extension Course should not be used in children under 6 years of
age.
Method of administration
For subcutaneous injection (see section 6.6 for instructions on handling).
It should be administered at a constant pressure by subcutaneous injection to the
middle third of the lateral posterior aspect of the upper arm. The injection sites should
be alternated between arms, e.g. 1st and 3rd injection in the right arm and 2nd injection
in the left arm. Repeated injections at one injection site should be avoided. Do not
inject into a blood vessel or intramuscularly. The patient should be instructed not to
rub the injection site.

4.3

Contraindications
Contraindicated in patients with asthma because they are more likely to
develop life threatening reactions.
Patients should not be given an allergy vaccine if they have febrile infections
or inflammation of the respiratory tract; irreversible secondary changes of the
reactive organs (emphysema, bronchiectasis etc); severe chronic and
inflammatory diseases, immunopathological conditions, active tuberculosis of
the lung and eyes, severe mental disorders or are receiving beta-blocker
therapy.
Hyposensitisation injections should not be given to patients with systemic or
local infection or who have suffered from a febrile condition in the 24 hours
preceding the intended dose, or if they have immunodeficiency or an
autoimmune disease.
If tyrosine metabolism is disturbed, especially in the case of tyrosinaemia and
alkaptonuria, or there is known hypersensitivity to any of the excipients
contained in POLLINEX Trees Extension Course (see section 6.1), the allergy
vaccine should not be used.
If the patient is pregnant/discover they become pregnant whilst receiving
treatment POLLINEX Trees Extension Course should not be started or
continued during pregnancy as pregnancy may change the patient's
sensitisation level to a degree that cannot be foreseen. Please refer to section
4.6 Fertility, pregnancy and lactation.

4.4

Special warnings and precautions for use
The individual tolerated dose should not be exceeded.
Treatment of patients should only be carried out where full facilities for cardiorespiratory resuscitation are immediately available.
Epinephrine/Adrenaline Injection should always be kept at hand when giving any
allergen specific immunotherapy.
Patients should be kept under observation for the first 60 minutes after each injection.
This period should be extended if even mild symptoms or signs of hypersensitivity
develop and patients should be maintained under observation until these have
completely resolved. A severe and prolonged adverse reaction may necessitate
hospital admission.
Anaphylactic shock
As with any specific immunotherapy there is a risk of anaphylactic shock.
Warning symptoms:
Tingling, itching and burning sensations on the tongue, in the mouth, throat or
particularly on the palms and soles. This may be immediately followed by shock with
cyanosis, hypotension, tachycardia, bronchospasm and unconsciousness.

Further clinical signs are: anxiety, restlessness, urticaria, dizziness, laryngeal oedema
with dyspnoea, nausea and vomiting, respiratory and cardiac arrest.
Severe and potentially life-threatening reactions require fast and effective emergency
treatment.
The treatment of allergic reactions is based on current medical guidelines.
In the event of simultaneous vaccination against viral or bacterial pathogens, there
should be an interval of at least one week between the last injection of the allergy
vaccine and the day of vaccination. Hyposensitisation therapy may be continued two
weeks after the vaccination, using half of the last dose administered. Afterwards, this
amount can be increased according to the dosage chart at intervals of 7-14 days.
Use with caution in patients with cardiovascular deficiency.
Patients should be warned not to eat a heavy meal immediately before an injection is
due to be given.
Injections should be given at a constant pressure by the subcutaneous route. Do not
inject into a blood vessel or intramuscularly. Do not rub the site of injection.
The patient should not take any strenuous physical exercise for 12 hours following
the injection.
All patients should be advised to contact the doctor immediately in the event of an
adverse reaction.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant therapy with symptomatic anti-allergic agents (e.g.
antihistamines, corticosteroids, mast cell stabilisers) may affect the tolerance
level of the patient. A reduction of the dose after discontinuing treatment with
these symptomatic preparations may be required.
During hyposensitisation, exposure to the causal allergens and allergens crossreacting with them is to be avoided as far as possible.
POLLINEX Trees Extension Course is contraindicated in those receiving
Beta-blockers, please refer to section 4.3.

4.6

Fertility, pregnancy and lactation
The use of POLLINEX Trees Extension Course is contraindicated in
pregnancy.

4.7

Effects on ability to drive and use machines
Occasionally the injection may cause mild drowsiness; the patient should be
instructed not to drive or operate machinery if this is the case.

4.8

Undesirable effects
If the injection intervals and dosage regimens are followed exactly and the dose is
individually increased in an appropriate manner, allergic side reactions to treatment
with the allergy vaccine are rare. They are usually mild but local and/or systemic

reactions must be anticipated, in which case the treatment must be immediately
discontinued. For these reasons an emergency kit should be immediately available.
As a precautionary measure, each patient must be kept under observation for at least
60 minutes after injections, after which time a medical assessment is made.
Reactions:
Local -

Systemic:
Mild -

Moderate-Severe -

Such as swelling or irritation.
These may require symptomatic treatment if they are severe or
persist. In extremely rare cases, granuloma may be observed,
especially if the injection was too superficial.
Such as rhinitis or urticaria.
Fatigue occasionally occurs after injection of the vaccine.
Atopic eczema may be exacerbated by hyposensitisation.
Such as severe wheezing or bronchospasm.

Description of selected adverse reactions
Anaphylactic reactions/anaphylactic shock
Severe anaphylactic reactions or anaphylactic shock have been reported in individual
cases. Anaphylactic shock can develop minutes after administration of any allergy
immunotherapy, often before a local reaction has appeared (see section 4.4).
Typical warning symptoms of anaphylactic shock are described in section 4.4.
In rare cases, adverse reactions may occur even a few hours after the
hyposensitisation injection, in which case the patient should inform their attending
doctor before the next injection. When in doubt especially after the appearance of
systemic reactions the patients should seek medical advice/treatment immediately.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms:
If a patient receives an overdose of an allergy vaccine, the likelihood of an adverse
reaction is increased.
Reactions are characterised by symptoms ranging from slight swelling or irritation at
the site of injection to anaphylaxis.
Management:
I)
See 4.8 Undesirable effects.
II)
The usual precautions should be followed i.e.
Patients should be kept under medical observation for at least 60 minutes after each
injection.

The patient should not take any strenuous physical exercise for 12 hours following
the injection.
All patients should be advised to contact the doctor immediately in the event of a
reaction.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: allergens
ATC Classification: V01A A05
Immunotherapy with POLLINEX Trees Extension Course is recommended for
patients who are sensitive to specific pollens. The effectiveness of
immunotherapy in reducing symptoms has been established by controlled,
blinded studies.
The specific pollen allergens incorporated in POLLINEX Trees Extension
Course have been modified by glutaraldehyde treatment and adsorbed onto Ltyrosine with the result that allergenicity is reduced (thus increasing tolerance)
while maintaining immunogenicity (related to efficacy).
Although the immunological events are not clearly understood, the production
of antigen specific IgG antibody, suppression of specific IgE and decreased
mediator (histamine) release from basophils are important factors.
Therapeutic effects of specific pollens immunotherapy are allergen-specific
and dose dependent.

5.2

Pharmacokinetic properties
POLLINEX Trees Extension Course contains glutaraldehyde-modified
extracts of specific pollens adsorbed onto L-tyrosine. The adsorbate L-tyrosine
is a natural amino acid which is metabolised in the body and ensures a slow
release of the active material (the allergoid) is released more slowly. This
results in a prolonged and efficient desensitising effect and improving
tolerance.

5.3

Preclinical safety data
No further information of relevance

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
L-Tyrosine
Liquefied Phenol
Sodium chloride
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Glycerol
Water for Injections

6.2

Incompatibilities
Not Applicable

6.3

Shelf life
3 years

6.4

Special precautions for storage
Store in a refrigerator (2ºC -8ºC).Do not freeze. Remove from the refrigerator
2-3 hours before use.

6.5

Nature and contents of container
The vial is a 3.0ml vial made from clear neutral glass (Type I, Ph. Eur.) fitted
with a butyl bung, aluminium seals and coloured flip tops.
The syringes are 1.0ml syringes made from clear neutral glass (Type 1,
Ph.Eur.) with a polypropylene plunger rod and butyl plunger.
A pack of POLLINEX Trees Extension Course contains:
Either
One multi-dose vial containing 1.5ml suspension as follows:
Vial No. 3 (Red) with 2000 SU/0.5ml
Or
Three unit dose pre-filled syringes containing 0.5ml as follows:
Syringe No. 3. (Red) with 2000 SU/0.5ml
A combination pack which includes the Primary Treatment Course (PL
17087/0007) is also available.
Packs containing the product in vials also contain empty syringes and needles
suitable for dispensing the product.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
The pack should be removed from the refrigerator 2-3 hours before use and
warmed to room temperature.
POLLINEX Trees Extension Course is a white opaque suspension. During
storage a white deposit with colourless supernatant may form. Therefore,
before use it is important to ensure that the syringe/vial is thoroughly shaken
to ensure that all of the sediment is evenly resuspended.

Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.

7

MARKETING AUTHORISATION HOLDER
Allergy Therapeutics (UK) Ltd
Dominion Way
Worthing
West Sussex
BN14 8SA

8

MARKETING AUTHORISATION NUMBER
PL 17087/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/08/1998 / 26/04/2005

10

DATE OF REVISION OF THE TEXT
02/03/2016

Expand Transcript

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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