ORALAIR

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Anthoxanthum odoratum; Phleum pratense; Poa pratensis; Lolium perenne; Dactylis glomerata

Dostępny od:

Stallergenes Australia Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

Consumer Medicine Information
ORALAIR 100IR and 300IR Sublingual Tablets
Ver 1.7
Page 1 of 7
CONSUMER MEDICINE INFORMATION
ORALAIR 
® 
Pronounced (O-ral-air)
_Contains the active ingredients of allergens from a mixture of 5
grass pollen_
_Table of contents_
_What is in the
leaflet ..................................................... p.1_
_What is Oralair used
for............................................... p.1_
_Before you are given
Oralair........................................ p.2_
_How Oralair is
given.................................................... p.3_
_While you are receiving
Oralair................................... p.4_
_Side
effects.................................................................... p.4_
_After using
Oralair ....................................................... p.6_
_Product
description ...................................................... p.6_
_Presentation.................................................................. p.6_
WHAT IS IN THIS LEAFLET
This  leaflet  answers  some  common  questions  about  Oralair Initiation Treatment  and  Oralair  Continuation 
Treatment sublingual tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Oralair against the 
expected benefits it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR.
WHAT IS ORALAIR USED FOR
Oralair contains an allergen extract. The  treatment  with  Oralair is  intended to  increase the  immunological 
tolerance towards certain grass pollen, and thereby reducing the
allergic symptoms.
Oralair is  used  for  the  treatment  of  certain  grass  pollen  allergy  that  is  characterised  by  rhinitis  (sneezing, 
runny  or  itchy  nose,  nasal  congestion)  with  or  without conjunctivitis  (itchy

Charakterystyka produktu

Product Information:
ORALAIR 100 IR and 300 IR sublingual tablets
Ver 2.1
Page 1 of 11
PRODUCT INFORMATION
NAME OF MEDICINE
ORALAIR INITIATION TREATMENT SUBLINGUAL TABLETS 100 IR & 300 IR 
(ALLERGEN POLLEN EXTRACT OF 5 GRASSES)
ORALAIR CONTINUATION TREATMENT SUBLINGUAL TABLETS 300 IR 
(ALLERGEN POLLEN EXTRACT OF 5 GRASSES)
DESCRIPTION
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.
EXCIPIENTS: Mannitol, Microcrystalline cellulose, Croscarmellose
sodium, Colloidal anhydrous silica, 
Magnesium stearate and 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.
PHARMACOLOGY
_PHARMACODYNAMIC PROPERTIES_
Pharmacotherapeutic group: Allergen extract, grass pollen
ATC code: V01AA02
_Mechanism of action _
ORALAIR  is  used  for  treatment  of  patients  with  specific  IgE-mediated  allergy  symptoms  such  as 
rhinitis with or without conjunctivitis caused by grass pollen.
The  immune  system  is  the  target  for