ORALAIR 100/300 Tablet Sublingual

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

GRASS POLLEN ALLERGEN EXTRACT

Dostępny od:

Stallergenes S.A.

INN (International Nazwa):

GRASS POLLEN ALLERGEN EXTRACT

Dawkowanie:

100/300

Forma farmaceutyczna:

Tablet Sublingual

Typ recepty:

Product subject to prescription which may be renewed (B)

Status autoryzacji:

Authorised

Data autoryzacji:

0000-00-00

Ulotka dla pacjenta

1
2
3
4
5
6
7
8
9
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 toleran-
ce 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 con-
junctivitis (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 tra-
ining and experience in allergic diseases, who will perform 
the appropriate skin and/or blood tests. 
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
ORALAIR 
DO NOT TAKE ORALAIR
•  if you are allergic to any of the other ingredients of this  
medicine (listed in section 6);
•  if you are taking beta-blockers (medicines prescribed for 
heart conditions and cardiovascular diseases, for example 
high blood pressure);
PREGNANCY AND BREAST-FEEDING
PREGNANCY
If you are pregnant, think you may be pregnant or are 
planning to have a baby, ask your doctor or pharmacist for 
advice before taking this m

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oralair 100IR & 300IR sublingual tablets
Initiation 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.
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 cutaneous test and/or a positive titre of the specific
IgE to the grass