POLLINEX TREES 300 800 AND 2000 SU/0.5ML SUSPENSION FOR INJECTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

POLLINEX T rees, 300 , 800 and 2000 Stand ardised Units (SU)/0.5ml, suspension for injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

POLLINEX Trees comprises of a series of 3 pre-filled vials or syringes in the following concentrations:

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

The a llergens h ave bee n c onverted into a llergoids b y treatment w ith glutaraldehyde and are adsorbed ont o L-tyrosine. The al lergen extracts are characterised and standardised th rough immunolog ical and bioche mical methods to ensure b atch-to-batch consistent aller gen 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

4   CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of se asonal a llergic ha yfever due to tre e polle n in a dults, adolescents and children from the a ge of 6 who have f ailed to res pond adequately to anti-allergy drugs.

The dia gnosis should be based on the ca reful consideration of the p atient’s history and allergy tests, preferably skin tests.

4.2 Posology and method of administration

Posology

POLLINEX Tre es is p resented in 3ml multi-dose via ls or thre e unit d ose syringes.

Each vial/s yringe is prefilled with 1.0ml/0.5 ml of vaccine in g raded concentrations as follows:

The injections should be given at interv als of 7 –14 da ys. Treatment is to be initiated with 0.5ml of vial/syringe No.1, followed 7–14 days later by 0.5ml of vial/syringe No. 2 and finally 7–14 days later by 0.5ml of vial/syringe No. 3, in accordance with the dosage regime above.

The a bove dos age regimen is suita ble for most pa tients in whom it is indicated. However, if the patient is particularly sensitive, then the dosage and the pro gression f rom dose to dose, s hould be modified acco rding to the clinician's dis­cretion.

The maximum dose of 0.5ml must not be exceeded.

The three graduated doses of POLLINEX Trees constitute a complete dose for one year.

The course should be completed before the onset of the tree pollen season. Do not use during the tree pollen season.

POLLINEX Tre es can b e followed b y a pr e-seasonal Ex tension Course (PL 17087/0008) for continued clinical improvement.

It is re commended that t he allergy vaccine should be given in each of th ree successive years.

Paediatric population

For children f rom the ag e of 6 years and adol escents, the same posolog y regime as adults is recommended.

Pollinex Trees 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 rig ht arm and 2nd injection in the left arm. Rep eated injections at one injection site should be avoid ed. Do not inject into a blood ve ssel or intramus cularly. The patient should be instructed not to rub the injection site.

4.3 Contraindications

Contraindicated in p atients with a sthma bec ause the y are more like ly to develop life threatening reactions.

Patients should not be given an allergy vaccine if they have febrile infections or inflammation of the r espiratory tract; irreversible secondary changes of the reactive or gans ( emphysema, bron chiectasis etc.); sev ere ch ronic and inflammatory diseases, immunopathological conditions, active tuberculosis of the lung and e yes, severe mental diso rders or are rec eiving bet a-blocker therapy.

Hyposensitisation injections should not be given to patients with systemic or local infection or who h ave suffered from a febrile condition in the 24 hours preceding th e intended dose, or if they hav e immunodeficienc y or an autoimmune disease.

If tyrosine metabolism is disturbed, esp ecially in the case of t yrosinaemia and alkaptonuria, or there is known h ypersensitivity to any of the excipients listed in section 6.1, the allergy vaccine should not be used.

If the p atient is preg nant/discover the y bec ome preg nant whilst re ceiving treatment PO LLINEX Trees should not be s tarted or continued during pregnancy as preg nancy may change the p atient's se nsitisation le vel to a degree that c annot be f oreseen. Pleas e ref er to section 4.6 Preg nancy 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.

Adrenaline (Epinephrine) 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 the rapy with s ymptomatic a nti-allergic ag ents (e.g. antihistamines, corticosteroids, mast cell stabilisers) may affect the tolerance level of the patient. A re duction 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 is contraindicated in those receiving Beta-blockers, please refer to section 4.3.

4.6 Fertility, pregnancy and lactation

The use of POLLINEX Trees is contraindicated in pregnancy (see section 4.3).

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.

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 is recommended for patients who are sensitive to specific poll ens. The effectiveness of immunotherapy in reducing symptoms has been established by controlled, blinded studies.

The speci fic pol len al lergens i ncorporated i n P OLLINEX T rees h ave been modified by glutaraldehyde treatment and adsorbed onto L-tyrosine with the result tha t a llergenicity is re duced (thus i ncreasing tole rance) 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 eff ects of s pecific pollens immunotherap y are alle rgen-specific and dose dependent.

5.2 Pharmacokinetic properties

POLLINEX Tr ees con tains g lutaraldehyde-modified ex tracts of spec ific pollens adsorbed onto L-tyrosine. The adsorbate L-tyrosine is a natural amino acid which is metabolised in the body and ensures that the active material (the allergoid) is rele ased more slowl y. This r esults in a prolonged and ef ficient desensitising effect and improves 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 (2 °C – 8°C). Do not freeze. Remove from refrigerator 23 hours before use.

6.5 Nature and contents of container

The vials are 3.0ml vials 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 either contains 3 multi-dose vials each containing 1.0ml suspension or 3 unit dose s yringes cont aining 0.5ml suspension in graded concentrations as follows:

Vial/Syringe No. 1. (Green) with 300 SU/0.5ml

Vial/Syringe No. 2. (Yellow) with 800 SU/0.5ml

Vial/Syringe No. 3. (Red) with 2000 SU/0.5ml

A combination pack which includes the Extension Course (PL 17087/0008) 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 th e refrigerator 2–3 hou rs before use and warmed to room temperature.

POLLINEX Tre es is a white opaque suspension. During stora ge a white deposit with c olourless supe rnatant ma y form. The refore, 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 unus ed medicin al product or w aste mate rial should be disposed o f in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Allergy Therapeutics (UK) Ltd

Dominion Way

Worthing

West Sussex

BN14 8SA

8 MARKETING AUTHORISATION NUMBER(S)

PL 17087/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

27/08/1998 / 26/04/2005