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POLLINEX GRASSES + RYE EXTENSION COURSE

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9082.002.106.2

Package Leaflet: Information for the User

POLLINEX Grasses + Rye
300 SU, 800 SU and 2000 SU/0.5 ml
suspension for injection

A llergy
Therapeutics

®

Transforming Allergy Treatment

POLLINEX Grasses + Rye
Extension Course
2000 SU/0.5 ml
suspension for injection

Tell your doctor or nurse if the interval between Pollinex Grasses + Rye injections is longer than 14
days, as they may need to reduce the dose of injection.
This allergy vaccine may be given for three consecutive years.
You must wait in the surgery/clinic for one hour after each injection. This may be longer if you
experience mild symptoms or signs of an allergic reaction and you will be kept under observation until
these symptoms have completely disappeared. If a side effect is severe and continues for a period of
time you may need to be admitted to hospital.
Do not rub the site of injection.
Do not take vigorous exercise for 12 hours after your injection.

Other vaccinations

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
In this leaflet:
1. What Pollinex Grasses + Rye is and what it is used for
2. Before you use Pollinex Grasses + Rye
3. How to use Pollinex Grasses + Rye
4. Possible side effects
5. How to store Pollinex Grasses + Rye
6. Further information

1. What Pollinex Grasses + Rye is and what it is used for
Pollinex Grasses + Rye is an allergy vaccine containing a mixture of modified extracts from 13 common grass pollens.
Pollinex Grasses + Rye is used to treat seasonal allergic hayfever (due to grass pollen) in patients 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 eyes. The modified grass pollen extracts in Pollinex Grasses + Rye are
released slowly to reduce potential side effects.
Your treatment will begin before the start of the grass pollen season.

2. Before you use Pollinex Grasses + Rye
Do not use Pollinex Grasses + Rye if

• you know you have an intolerance to phenol, glycerol or any of the other non active ingredients in
the vaccine (listed in section 6 ’ Further information’)
• 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 (causing brown colouring of the skin and eyes, damage to joints and
passing black urine)
• you have any type of infection (also HIV/AIDS)
• you have had a high temperature in the last 24 hours
• you are taking beta-blockers e.g. Atenolol used in the treatment of conditions such as high blood
pressure and heart problems.

Take special care with Pollinex Grasses + Rye

It is important to tell your doctor if you suffer from any heart related medical condition. You
may be able to use Pollinex Grasses + Rye, but need to discuss with your doctor first.
Do not eat a heavy meal immediately before you are due to have an injection.

Taking other medicines
• Do not take Pollinex Grasses + Rye if you are taking beta-blockers.
• Talk to your doctor, nurse or pharmacist before having Pollinex Grasses + Rye if you are taking any
of the following medicines:
- Antihistamines e.g. Cetirizine used in the treatment of conditions such as hayfever, rash and
swelling of the face and throat
- Corticosteroids e.g. Beclometasone used in the treatment of conditions such as asthma,
running nose and nasal congestion
- Mast Cell Stabilisers e.g. Sodium Cromoglycate used in the treatment of conditions such as
running nose, nasal congestion, asthma and itchy or sore eyes.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.

Pregnancy and breast feeding

You should not use Pollinex Grasses + Rye if you are pregnant, think you might be pregnant or are
breast feeding.

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.

Important information about some of the ingredients of Pollinex Grasses + Rye

Pollinex Grasses + Rye is essentially ’
‘sodium free’ since it contains less than 1 mmol sodium (23 mg) per dose.

3. How to use Pollinex Grasses + Rye

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 Grasses + Rye and the day of the other vaccination.
The next dose of Pollinex Grasses + Rye may be administered two weeks after the other vaccination
provided that all side effects of the other vaccination have completely disappeared.

If you are given more Pollinex Grasses + Rye than you should

As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose.
Tell your doctor or nurse if you have any concerns about the amount of medicine that you are given.

If you forget to use Pollinex Grasses + Rye

It is important that Pollinex Grasses + Rye injections are given at the right time. Tell your doctor or nurse
if the interval between Pollinex Grasses + Rye injections is longer than 14 days, as they may need to
reduce the dose of injection.

If you stop using Pollinex Grasses + Rye

If you stop having Pollinex Grasses + Rye without the advice of your doctor, your symptoms may get worse.
If you have any further questions on the use of this product, please ask your doctor.

4. Possible side effects
Like all medicines, Pollinex Grasses + Rye 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 Grasses + Rye. 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 a few seconds to minutes after the allergy vaccine injection,
often before a local reaction has appeared. An emergency kit will be available.

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.

Tell your doctor, nurse or pharmacist as soon as possible if you notice any of these side effects.
If you experience any side effects after your injection, or if you notice any side effects not listed
in the leaflet, inform your doctor before you receive your next dose.

5. How to store Pollinex Grasses + Rye
Keep out of the reach and sight 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 after the expiry date which is stated on the packaging. The expiry date refers to the last
day of that month
• Do not use if there are any visible signs of deterioration
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.





6. Further information
What Pollinex Grasses + Rye contains:

• The active substances are the allergoids.
Pollinex Grasses + Rye contains equal proportions
of 13 selectively purified allergoids of pollen
allergens from the following grasses:
- Foxtail (Alopecurus pratensis)
- Crested Dogstail (Cynosurus cristatus)
- Cocksfoot (Dactylis glomerata)
- Rye grass (Lolium perenne)
- Meadow grass (Poa pratensis)
- Vernal (Anthoxanthum odoratum)
- Fescue (Festuca pratensis)
- Bent (Agrostis tenuis)
- Timothy (Phleum pratense)
- Brome (Bromus spp.)
- Oat grass (Arrhenatherum elatius)
- Yorkshire Fog (Holcus lanatus)
- Cultivated Rye (Secale cereale).

• The other non active ingredients are:
- L-Tyrosine
- Phenol
- Sodium Chloride
- Disodium Phosphate Dodecahydrate
- Sodium Dihydrogen Phosphate Dihydrate
- Glycerol
- Water for Injections.

Your medicine has been prescribed by and will be given to you under the supervision of a qualified doctor.
They will be equipped with full facilities for cardio respiratory resuscitation to deal with any severe
reaction to the vaccine.

What Pollinex Grasses + Rye looks like and the contents of the pack:

Pollinex Grasses + Rye vaccine is injected slowly under the skin.

Pollinex Grasses + Rye Initial Course consists of:
3 vials each containing 1.0 ml suspension

Children under the age of 6 should not be given Pollinex Grasses + Rye.

Pollinex Grasses + Rye and Pollinex Grasses + Rye Extension Course is a white opaque suspension for
injection.

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

Treatment plan

Pollinex Grasses + Rye Initial Course

Three doses, in increasing strengths (300, 800, then
2000 Standardised units) given as separate injections.
Interval of 7-14 days between injections.

Pollinex Grasses + Rye Extension Course
(may be given after the initial course)

Three doses of 2000 Standardised units given as
separate injections.
The first injection is given about 14 days after the
initial course is finished; the other injections are
usually given at intervals of 2-4 weeks.
If the hayfever season is due to start shortly, the
interval can be reduced to 1 week.

No. 1 Vial 300 SU/0.5 ml Green
No. 2 Vial 800 SU/0.5 ml Yellow
No. 3 Vial 2000 SU/0.5 ml Red

Pollinex Grasses + Rye Extension Course consists of:
1 vial containing 1.5 ml suspension

No. 1 Vial 2000 SU/0.5 ml Red

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

Marketing Authorisation Holder and Manufacturer
Allergy Therapeutics (UK) Ltd., Dominion Way, Worthing,
West Sussex, BN14 8SA, United Kingdom.

A llergy
Therapeutics

®

Transforming Allergy Treatment

This leaflet was approved in 06/2008

© Allergy Therapeutics (UK) Ltd.

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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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