POLLINEX TREES EXTENSION COURSE 2000 SU/0.5ML SUSPENSION FOR INJECTION - patient leaflet, side effects, dosage

Pollinex Trees is an allergy vaccine containing a mixture of modified extracts from Birch, Alder and Hazel pollen.

Pollinex Trees is used to treat seasonal allergic hayfever (due to tree pollen) in adults, adolescents and children from the age of 6 years who have not responded well to

anti-allergy drugs. In hayfever, contact with high levels of pollen causes sneezing, blocked and runny nose and burning/watery

Pollinex Trees are released slowly to reduce

Your treatment will begin before the start of

eyes. The modified tree pollen extracts in

potential side effects.

the tree pollen season.

Do not use Pollinex Trees if

• you know you have a hypersensitivity to any of the other (non active) ingredients of this medicine (listed in section 6)
• you are pregnant or think you might be pregnant
• you have lung problems such as asthma, emphysema, bronchiectasis
• you have a severe mental disorder such as depression or schizophrenia

you have active tuberculosis of the lungs

or eyes

you have any autoimmune disease such as:

• - Rheumatoid arthritis (which affects your joints)

• - Addison’s disease (which affects the production of hormones in the body)

• – a type of hepatitis (liver disease)

• – a type of diabetes (type I)

• - Multiple sclerosis (a degenerative disease)

you have any disorder of tyrosine metabolism including tyrosinaemia (increased

blood levels of tyrosine) and alkaptonuria

eyes, damage to joints and passing black urine) you have any type of infection (also HIV/AIDS )

(causing brown colouring of the skin and

you have had a high temperature in the la you are taking beta-blockers e.g. Atenolol high blood pressure and heart problems.

st 24 hours

used in the treatment of conditions such as

Warnings and precautions

Talk to your doctor or nurse before using P<

ollinex Trees if:

• you suffer from any heart related medical

—Trees, but need to discuss with your docto before you are due to have an injection.

Other medicines and Pollinex Trees

condition. You may be able to use Pollinex r first. Do not eat a heavy meal immediately

Do not take Pollinex Trees if you are taking beta-blockers.

Talk to your doctor, nurse or pharmacist before having Pollinex Trees if you are taking any of the following medicines:

– Antihistamine s e.g. Cetirizine used in the treatment of conditions such as hayfever,

rash and swelling of the face and throat

– Corticosteroids e.g. Beclometasone use asthma, running nose and nasal congesti

d in the treatment of conditions such as ion

– Mast Cell Stabilisers e.g. Sodium Cromoglicate used in the treatment of conditions

such as running nose, nasal congestion,

asthma and itchy or sore eyes.

Tell your doctor if you are taking, have recen

tly taken or might take any other medicines.

Pollinex Trees with food, drink and alcohol

Do not eat a heavy meal immediately before an injection is due to be given.

Pregnancy and breast feeding

You should not use Pollinex Trees if you are breast feeding.

pregnant, think you might be pregnant or are

Driving and using machines

Occasionally the injection may cause mild drowsiness ; you should not drive or use tools or machinery if you experience this symptom.

Pollinex Trees contains sodium

Pollinex Trees is essentially ‘sodium free’ sin (23 mg) per dose.

ce it contains less than 1 mmol sodium

Your medicine has been prescribed by and of a qualified doctor. They will be equipped resuscitation to deal with any severe reactio

will be given to you under the supervision with full facilities for cardio respiratory

n to the vaccine.

Pollinex Trees vaccine is injected at a const

Use in children

ant pressure under the skin.

Children under the age of 6 should not be given Pollinex Trees.

You should not be given this vaccine during the tree pollen season.

The recommended doses are as follows:

Allergy

Therapeutics

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Do not rub the site of injection.

Do not take vigorous exercise for 12 hours after your injection.

Other vaccinations

If you are due to have any other type of vaccination , (for example a flu jab) there should be an interval of at least one week between your last injection of Pollinex Trees and the day of the other vaccination.

The next dose of Pollinex Trees may be administered two weeks after the other vaccination

provided that all side effects of the other vacc

If you are given more Pollinex Trees As a doctor or nurse will be giving you your m incorrect dose. Tell your doctor or nurse if yo medicine that you are given.

If you forget to use Pollinex Trees

I t is i mportant that Po llinex T rees i njections a

ination have completely disappeared.

than you should

edicine, it is unlikely that you will receive an u have any concerns about the amount of

re given at the right time. Tell your doctor or

nurse if the interval between Pollinex Trees injections is longer than 14 days, as they may need to reduce the dose of injection.

If you stop using Pollinex Trees

If you stop having Pollinex Trees without the advice of your doctor, your symptoms may get worse.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, Pollinex Trees can cause side effects, although not everybody gets them.

Get urgent medical treatment immediately if you notice a severe allergic reaction, known as an anaphylactic shock after taking Pollinex Trees. Symptoms include:

• General itching and feeling of heat – especially affecting scalp, mouth, throat, palms or soles
• Severe wheezing, or noisy or difficult breathing
• Severe hives/nettle rash
• Swelling of the lips or throat
• Pale or greyish skin colour
• A fast heart beat
• Faintness or collapse.

Anaphylactic shock can develop minutes a

fter the allergy vaccine injection, often

before a local reaction has appeared. An emergency kit will be available.

If you experience any side effects after your injection, inform your doctor before you receive your next dose.

Other side effects include:

• Swelling or irritation at the site of injection
• A lump or nodule of inflamed tissue (granuloma) at the site of injection
• Tiredness
• Eczema may become worse
• Running nose, sneezing
• Difficulty breathing or wheezing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme:

Website:.

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Store in a refrigerator between 2°C and 8°C

Do not freeze.

The pack should be removed from the fridge 2–3 hours before use.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Pollinex Trees contains:

• The active substances are the allergoids.

Pollinex Trees contains equal proportions of 3 selectively purified allergoids of pollen allergens from the following Trees:

• – Birch (Betula spp. )

• – Alder (Alnus spp. )

• – Hazel (Corylus spp. )

• The other ingredients are:

• – L-Tyrosine

• – Liquefied Phenol

• – Sodium Chloride

• – Disodium Phosphate Dodecahydrate

• – Sodium Dihydrogen Phosphate Dihydrate

• – Glycerol

• – Water for Injections.

Course is a white opaque suspension for

Pollinex Trees Initial Course consists of:

The product is also supplied in a pack containing both the Initial Course and the

Extension Course.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Allergy Therapeutics (UK) Ltd. Dominion Way, Worthing, West Sussex BN14 8SA. United Kingdom

This leaflet was last revised in 11/2020.

date started : 14/04/20

date revised : 02/11/20

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Allergy Therapeutics

9087.002.106.6

Technical User Leaflet

POLLINEX

Trees

• 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 cross-reacting 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).

Allergy Therapeutics

• 4.7 Effects on ability to drive and use machines

Occasionally the injection may cause mild drowsiness; the patient should b

• 4.8 Undesirable effects

e instructed not to drive or operate machinery if this is the case.

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 emergen

cy 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:

1. NAME OF THE MEDICINAL PRODUCT

POLLINEX Trees, 300, 800 and 2000 Standardised Units (SU)/0.5 ml, suspension for injection

POLLINEX Trees Extension Course, 2000 Standardised Units (SU)/0.5 ml, suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

POLLINEX Trees treatment comprises a series of 4 pre-filled vials/6 pre-filled syringes in the following concentrations:

POLLINEX Trees 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 hayfever due to tree pollen in adults, adolescents and children from the age of 6 years 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 is presented in three multi-dose 3 ml vials or three unit dose 1 ml syringes. Each vial/syringe is prefilled with 1.0 ml/0.5 ml vaccine respectively in graded concentrations as follows:

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

The above dosage regimen is suitable for most patients in whom it is indicated. However, if the patient is particularly sensitive, then the dosage and the progression from dose to dose, should be modified according to the clinician’s dis­cretion.

The maximum dose of 0.5 ml must not be exceeded.

The course should be completed before the onset of the tree pollen season. POLLINEX Trees can be followed by the pre-seasonal Extension Course incl

. Do not use during the tree pollen season.

luded in this pack for continued clinical improvement.

The Extension Course consists of three injections of the maximum dose of 2000 SU/0.5 ml. If the maximum dose is not tolerated, treatment can take place at a lower dose. The first injection of 0.5 ml 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.

It is recommended that the allergy vaccine should be given in each of three '

Paediatric population

successive years.

For children from the age of 6 years and adolescents, the same posology 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 injection sites should be alternated between arms, e.g. 1st and 3rd injection

to the middle third of the lateral posterior aspect of the upper arm. The 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 if there is a known hypersensitivity to any of the excipients listed in section 6.1, POLLINEX Trees should not be used.

If the patient is pregnant/discover they become pregnant whilst receiving treatment POLLINEX Trees 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 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 cardio-respiratory 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 obser 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

vation until these have completely resolved. A severe and prolonged

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 e The treatment of allergic reactions is based on current medical guidelines.

mergency treatment.

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 POLLINEX Trees and the day of vaccination provided all side effects (local or systemic) have completely disappeared. The next dose of POLLINEX Trees may be administered two weeks after the vaccination, provided that all side effects to the vaccination have completely disappeared, using half

of the last dose administered.

Afterwards, this amount can be increased according to the dosage chart at Use with caution in patients with cardiovascular deficiency.

ntervals of 7–14 days.

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 foll All patients should be advised to contact the doctor immediately in the eve

lowing the injection.

nt of an adverse reaction.

Local – 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.

Systemic:

Mild – Such as rhinitis or urticaria.

Fatigue occasionally occurs after injection of the vaccine.

Atopic eczema may be exacerbated by hyposensitisation.

Moderate-Severe – 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 appearai advice/treatment immediately.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

nce of systemic reactions the patients should seek medical

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:

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:

• 1) See 4.8 Undesirable effects.

• 2) 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 foll All patients should be advised to contact the doctor immediately in the eve

5. PHARMACOLOGICAL PROPERTIES

lowing the injection. nt of a reaction.

5.1 Pharmacody­namic properties

Pharmacotherapeutic group: allergens, ATC Classification: V01A A05.

Immunotherapy with POLLINEX Trees is recommended for patients who are reducing symptoms has been established by controlled, blinded studies.

sensitive to specific pollens. The effectiveness of immunotherapy in

The specific pollen allergens incorporated in POLLINEX Trees have been modified by glutaraldehyde treatment and adsorbed onto tyrosine 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 producti decreased mediator (histamine) release from basophils are important factor

The therapeutic effects of specific pollens immunotherapy are allergen-spe

5.2 Pharmacoki­netic properties

ion of antigen specific IgG antibody, suppression of specific IgE and rs.

cific and dose dependent.

POLLINEX Trees 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 that the active material (the allergoid) is released more slowly. This results in a prolonged and efficient 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 2–3 hours before use.

• 6.5 Nature and contents of container

The vials are 3.0 ml vials made from clear neutral glass (Type I, Ph. Eur.) fitted with a butyl bung, aluminium seals and coloured flip tops.

The pre-filled syringes are 1.0 ml syringes made from clear neutral glass (Typ

A pack of POLLINEX Trees contains 3 multi-dose vials each containing 1.0 m concentrations as follows:

e 1, Ph. Eur.) with a polypropylene plunger rod and a butyl plunger.

l suspension or 3 unit dose syringes containing 0.5 ml suspension in graded

Vial/Syringe No. 1.

Vial/Syringe No. 2.

Vial/Syringe No. 3.

(Green) (Yellow) (Red)

with with with

300 SU/0.5 ml

800 SU/0.5 ml

2000 SU/0.5 ml

The included Extension Course consists of one multi-dose vial containing 1.5 ml of suspension or 3 additional unit dose pre-filled syringes containing 0.5 ml of suspension as follows:

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

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 and other handling

The pack should be removed from the refrigerator at least 2–3 hours before

use and warmed to room temperature.

POLLINEX Trees 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 vial/syringe is thoroughly shaken to ensure that

all of the sediment is evenly re-suspended.

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

8. MARKETING AUTHORISATION NUMBER

8SA, United Kingdom.

PL 17087/0007

PL 17087/0008

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE AUTHORISATION

Date of first authorisation: 27 August 1998

Date of latest renewal: 26 April 2005

10. DATE OF (PARTIAL) REVISION OF TEXT

04/2020

Allergy Therapeutics

DOSAGE PLAN:

POLLINEX Trees and

POLLINEX Trees Extension Course

Apply Patient Label Here (or enter patient details)

Treatment Course

Interval between each injection should be 7–14 days

Extension Course

If the pollen season is imminent, the interval between each injection may

be reduced to 1 week

Allergy Therapeutics

artwork version

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Allergy

Therapeutics

Allergy Therapeutics (UK) Ltd, Dominion Way, Worthing, West Sussex, BN14 8SA, United Kingdom

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Allergy Therapeutics

Leaflet

Pollinex Trees

font usage : Okomito family main text size : 7pt

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9087.002.106.6

Technical User Leaflet

POLLINEX

Trees

• 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 cross-reacting 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).

Allergy Therapeutics

• 4.7 Effects on ability to drive and use machines

Occasionally the injection may cause mild drowsiness; the patient should b

• 4.8 Undesirable effects

e instructed not to drive or operate machinery if this is the case.

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 emergen

cy 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:

1. NAME OF THE MEDICINAL PRODUCT

POLLINEX Trees, 300, 800 and 2000 Standardised Units (SU)/0.5 ml, suspension for injection

POLLINEX Trees Extension Course, 2000 Standardised Units (SU)/0.5 ml, suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

POLLINEX Trees treatment comprises a series of 4 pre-filled vials/6 pre-filled syringes in the following concentrations:

POLLINEX Trees 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 hayfever due to tree pollen in adults, adolescents and children from the age of 6 years 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 is presented in three multi-dose 3 ml vials or three unit dose 1 ml syringes. Each vial/syringe is prefilled with 1.0 ml/0.5 ml vaccine respectively in graded concentrations as follows:

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

The above dosage regimen is suitable for most patients in whom it is indicated. However, if the patient is particularly sensitive, then the dosage and the progression from dose to dose, should be modified according to the clinician’s dis­cretion.

The maximum dose of 0.5 ml must not be exceeded.

The course should be completed before the onset of the tree pollen season. POLLINEX Trees can be followed by the pre-seasonal Extension Course incl

. Do not use during the tree pollen season.

luded in this pack for continued clinical improvement.

The Extension Course consists of three injections of the maximum dose of 2000 SU/0.5 ml. If the maximum dose is not tolerated, treatment can take place at a lower dose. The first injection of 0.5 ml 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.

It is recommended that the allergy vaccine should be given in each of three '

Paediatric population

successive years.

For children from the age of 6 years and adolescents, the same posology 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 injection sites should be alternated between arms, e.g. 1st and 3rd injection

to the middle third of the lateral posterior aspect of the upper arm. The 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 if there is a known hypersensitivity to any of the excipients listed in section 6.1, POLLINEX Trees should not be used.

If the patient is pregnant/discover they become pregnant whilst receiving treatment POLLINEX Trees 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 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 cardio-respiratory 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 obser 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

vation until these have completely resolved. A severe and prolonged

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 e The treatment of allergic reactions is based on current medical guidelines.

mergency treatment.

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 POLLINEX Trees and the day of vaccination provided all side effects (local or systemic) have completely disappeared. The next dose of POLLINEX Trees may be administered two weeks after the vaccination, provided that all side effects to the vaccination have completely disappeared, using half

of the last dose administered.

Afterwards, this amount can be increased according to the dosage chart at Use with caution in patients with cardiovascular deficiency.

ntervals of 7–14 days.

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 foll All patients should be advised to contact the doctor immediately in the eve

lowing the injection.

nt of an adverse reaction.

Local – 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.

Systemic:

Mild – Such as rhinitis or urticaria.

Fatigue occasionally occurs after injection of the vaccine.

Atopic eczema may be exacerbated by hyposensitisation.

Moderate-Severe – 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 appearai advice/treatment immediately.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

nce of systemic reactions the patients should seek medical

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:

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:

• 1) See 4.8 Undesirable effects.

• 2) 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 foll All patients should be advised to contact the doctor immediately in the eve

5. PHARMACOLOGICAL PROPERTIES

lowing the injection. nt of a reaction.

5.1 Pharmacody­namic properties

Pharmacotherapeutic group: allergens, ATC Classification: V01A A05.

Immunotherapy with POLLINEX Trees is recommended for patients who are reducing symptoms has been established by controlled, blinded studies.

sensitive to specific pollens. The effectiveness of immunotherapy in

The specific pollen allergens incorporated in POLLINEX Trees have been modified by glutaraldehyde treatment and adsorbed onto tyrosine 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 producti decreased mediator (histamine) release from basophils are important factor

The therapeutic effects of specific pollens immunotherapy are allergen-spe

5.2 Pharmacoki­netic properties

ion of antigen specific IgG antibody, suppression of specific IgE and rs.

cific and dose dependent.

POLLINEX Trees 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 that the active material (the allergoid) is released more slowly. This results in a prolonged and efficient 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 2–3 hours before use.

• 6.5 Nature and contents of container

The vials are 3.0 ml vials made from clear neutral glass (Type I, Ph. Eur.) fitted with a butyl bung, aluminium seals and coloured flip tops.

The pre-filled syringes are 1.0 ml syringes made from clear neutral glass (Typ

A pack of POLLINEX Trees contains 3 multi-dose vials each containing 1.0 m concentrations as follows:

e 1, Ph. Eur.) with a polypropylene plunger rod and a butyl plunger.

l suspension or 3 unit dose syringes containing 0.5 ml suspension in graded

Vial/Syringe No. 1.

Vial/Syringe No. 2.

Vial/Syringe No. 3.

(Green) (Yellow) (Red)

with with with

300 SU/0.5 ml

800 SU/0.5 ml

2000 SU/0.5 ml

The included Extension Course consists of one multi-dose vial containing 1.5 ml of suspension or 3 additional unit dose pre-filled syringes containing 0.5 ml of suspension as follows:

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

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 and other handling

The pack should be removed from the refrigerator at least 2–3 hours before

use and warmed to room temperature.

POLLINEX Trees 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 vial/syringe is thoroughly shaken to ensure that

all of the sediment is evenly re-suspended.

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

8. MARKETING AUTHORISATION NUMBER

8SA, United Kingdom.

PL 17087/0007

PL 17087/0008

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE AUTHORISATION

Date of first authorisation: 27 August 1998

Date of latest renewal: 26 April 2005

10. DATE OF (PARTIAL) REVISION OF TEXT

04/2020

Allergy Therapeutics

DOSAGE PLAN:

POLLINEX Trees and

POLLINEX Trees Extension Course

Apply Patient Label Here (or enter patient details)

Treatment Course

Interval between each injection should be 7–14 days

Extension Course

*If the pollen season is imminent, the interval between each injection may

be reduced to 1 week

Allergy Therapeutics

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Allergy

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Allergy Therapeutics (UK) Ltd, Dominion Way, Worthing, West Sussex, BN14 8SA, United Kingdom

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Pollinex Trees

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