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POLLINEX GRASSES + RYE EXTENSION COURSE 2000 SU/0.5ML SUSPENSION FOR INJECTION

Active substance(s): 13 GRASS MIX GLUTERALDEHYDE MODIFIED

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9082.002.106.4

Package Leaflet: Information for the User

POLLINEX Grasses + Rye

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.

300, 800 and 2000 Standardised Units (SU)/0.5ml, suspension for injection
Grass pollen allergens (chemically modified, adsorbed onto L-tyrosine)

POLLINEX Grasses + Rye Extension Course
2000 Standardised Units (SU)/0.5ml, suspension for injection
Grass pollen allergens (chemically modified, adsorbed onto L-tyrosine)

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

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.
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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

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.

What is in this leaflet:

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.

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6.

What Pollinex Grasses + Rye is and what it is used for
What you need to know before you use Pollinex Grasses + Rye
How to use Pollinex Grasses + Rye
Possible side effects
How to store Pollinex Grasses + Rye
Contents of the pack and other 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 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 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. What you need to know before you use Pollinex Grasses + Rye
Do not use Pollinex Grasses
’ + Rye 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 (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.

Warnings and precautions

Talk to your doctor or nurse before using Pollinex Grasses + Rye 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.

Other medicines and Pollinex Grasses + Rye

• 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 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 recently taken or might take any other medicines.

Pollinex Grasses + Rye 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 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.

Pollinex Grasses + Rye contains sodium

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

3. How to use Pollinex Grasses + Rye
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.
Pollinex Grasses + Rye vaccine is injected at a constant pressure under the skin.

Use in children

Children under the age of 6 should not be given Pollinex Grasses + Rye.
You should not be given this vaccine during the grass pollen season.

The recommended doses are as follows:
Pollinex Grasses + Rye Initial Course

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

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

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

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 medicine, please ask your doctor or nurse.

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 minutes after 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pollinex Grasses + Rye





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.

6. Contents of the pack and other 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 ingredients are:
- L-Tyrosine
- Liquefied Phenol
- Sodium Chloride
- Disodium Phosphate Dodecahydrate
- Sodium Dihydrogen Phosphate Dihydrate
- Glycerol
- Water for Injections.

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

Pollinex Grasses + Rye and Pollinex Grasses + Rye Extension Course is a white opaque suspension for injection.
Pollinex Grasses + Rye Initial Course consists of:
3 multi-dose vials each containing 1.0ml
suspension/3 pre-filled unit dose syringes
each containing 0.5ml suspension
Pollinex Grasses + Rye Extension Course consists of:
1 multi-dose vial containing 1.5ml
suspension/3 pre-filled unit dose syringes
containing 0.5ml suspension

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

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 11/2015.

A llergy
Therapeutics

®

Transforming Allergy Treatment

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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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