Oralair 100IR & 300IR sublingual Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GRASS POLLEN, ALLERGEN EXTRACT

Available from:

Stallergenes S.A. 6 rue Alexis de Tocqueville, 92160 Antony, France

ATC code:

V01AA02

INN (International Name):

GRASS POLLEN ALLERGEN EXTRACT

Pharmaceutical form:

SUBLINGUAL TABLET

Composition:

GRASS POLLEN ALLERGEN EXTRACT

Prescription type:

POM

Therapeutic area:

ALLERGENS

Authorization status:

Withdrawn

Authorization date:

2010-02-17

Patient Information leaflet

1

PACKAGE LEAFLET: INFORMATION FOR THE USER 

ORALAIR 100 IR & 300 IR SUBLINGUAL TABLETS 

For use in adults, adolescents and children above the age of 5  

Initiation treatment 

Grass pollen allergen extract from: 
Cocksfoot (_Dactylis glomerata_ L.), Sweet vernal grass
(_Anthoxanthum odoratum_ L.), Rye grass 
(_Lolium perenne_ L.), Meadow grass (_Poa pratensis_ L.) and
Timothy (_Phleum pratense_ L.) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
or pharmacist. 
- 
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm 
them, even if their signs of illness are the same as yours. 
- 
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 
1. 
What ORALAIR is and what it is used for 
2. 
What you need to know before you take ORALAIR  
3. 
How to take ORALAIR  
4.  
Possible side effects 
5 
How to store ORALAIR  
6. 
Content of the pack and other information 

1. 
WHAT ORALAIR IS AND WHAT IT IS USED FOR 

ORALAIR contains an allergen extract. The treatment with ORALAIR is
intended to increase 
the immunological tolerance towards grass pollens, and
thereby reducing the allergic symptoms. 

ORALAIR is used for the treatment of grass pollen allergy that is
characterised by rhinitis 
(sneezing, runny or itchy nose, nasal congestion) with or without
conjunctivitis (itchy and 
watery eyes) in adults, adolescents and children from the age of
5 years. 

Before treatment is started, your allergy will be diagnosed
by a doctor with adequate training 
and experience in allergic diseases, who will perform the appropriate
skin and/or blood tests.  

2

Summary of Product characteristics

Page 1 of 14 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

ORALAIR 100 IR & 300 IR SUBLINGUAL TABLETS 
Initiation treatment 

ORALAIR 300 IR SUBLINGUAL TABLETS 
Continuation treatment 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Grass pollen allergen extract from: Cocksfoot (_Dactylis
glomerata_ L.), Sweet vernal grass 
(_Anthoxanthum odoratum_ L.), Rye grass (_Lolium perenne_ L.),
Meadow grass (_Poa pratensis_ L.) 
and Timothy (_Phleum pratense_ L.)
…………………................100 IR* or 300 IR* per 
sublingual tablet. 

* IR (Index of Reactivity) : The unit IR has been defined to
measure the allergenicity of an 
allergen extract. The allergen extract contains 100 IR/ml when,
on a skin prick-test using a 
Stallerpoint
®
, it induces a wheal diameter of 7 mm in 30 patients sensitized to
this allergen, 
(geometric mean). The cutaneous reactivity of these patients is
simultaneously demonstrated by 
a positive skin prick-test to either 9 % codeine phosphate or 10
mg/ml histamine. The IR unit of 
Stallergenes is not comparable to the units used by other allergen
manufacturers._ _

Excipient with known effect: Lactose monohydrate. 

One sublingual tablet of 100 IR contains 83.1 – 83.6
mg Lactose monohydrate. 
One sublingual tablet of 300 IR contains 81.8 – 83.1mg
Lactose monohydrate. 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Sublingual tablet. 

The tablets of 100 IR are slightly speckled white to beige,
engraved “100” on both surfaces. 
The tablets of 300 IR are slightly speckled white to beige,
engraved “300” on both surfaces. 

Page 2 of 14 

4. 
CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Treatment of grass pollen allergic rhinitis with or without
conjunctivitis in adults, adolescents 
and children (above the age of 5) with clinically relevant symptoms,
confirmed by a positive 
c