Oralair 300 IR sublingual tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Grass pollen allergen extract

Available from:

STALLERGENES

ATC code:

V01AA; V01AA02

INN (International Name):

Grass pollen allergen extract

Dosage:

300 Index of Reactivity

Pharmaceutical form:

Sublingual tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Allergen extracts; grass pollen

Authorization status:

Marketed

Authorization date:

2010-02-19

Patient Information leaflet

STALLERGENES
1.3.1 SPC, Labelling and PL
(PL ORALAIR 300 IR IE)
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ORALAIR 300 IR SUBLINGUAL TABLETS
For use in adults, adolescents and children above the age of 5
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.
Contents 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.
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

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2023
CRN00DFNG
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oralair 300 IR sublingual tablets
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 dihydrochloride. The IR unit of Stallergenes is
not comparable to the units used by other allergen manufacturers.
Excipient with known effect:
One sublingual tablet of 100 IR contains 83.1 – 83.6 mg of lactose
monohydrate.
One sublingual tablet of 300 IR contains 81.7 – 83.2 mg of lactose
monohydrate.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Sublingual tablet.
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 one of the
grass pollen from the Pooideae grass homologous group
1
.
_1 _
_ Pooideae (temperate) grass homologous group: Phleum pratense
(Timothy grass), Anthoxanthum odoratum (Sweet vernal grass), _
_Avena _
_sativa _
_(Oat), _
_Dactylis _
_glomerata _
_(Orchard _
_gr