Oralair

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Grass pollen extract 100 IR; Allergen extracts 300 IR (grass pollen)

Dostupné s:

Stallergenes Greer New Zealand Ltd

INN (Mezinárodní Name):

Grass pollen extract 100 IR

Léková forma:

Sublingual tablet

Složení:

Active: Grass pollen extract 100 IR Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose Active: Allergen extracts 300 IR (grass pollen) Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose

Jednotky v balení:

Blister pack, 3 x 100 IR, 7 x 300 IR, 10 tablets

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Stallergenes

Terapeutické indikace:

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 pollen.

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, 3 x 100 IR, 7 x 300 IR - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, 3 x 100 IR, 28 x 300 IR - 31 tablets - 36 months from date of manufacture stored at or below 30°C

Datum autorizace:

2010-11-26

Informace pro uživatele

Consumer Medicine Information
ORALAIR 100IR and 300IR Sublingual Tablets
Ver 3.4
Page 1 of 8
CONSUMER MEDICINE INFORMATION
ORALAIR
®
Pronounced (O-ral-air)
_Contains the active ingredients of allergens from a mixture of 5
grass pollens_
_ _
_ _
_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.5 _
_Side effects
....................................................................
p.7 _
_After using Oralair
....................................................... p.7 _
_Product description
...................................................... p.7 _
_Presentation
.................................................................. p.8
_
_ _
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. Treatment with Oralair is
intended to increase the immunological tolerance
towards certain grass pollens, thereby reducing the allergic symptoms.
Oralair is used for the treatment of certain grass pollen allergies
that are characterised by rhinitis (sneezing,
runny or itchy nose, nasal congestion) with or without conjunctivitis
(itchy and watery eyes) in adults,
adolescents and children above the age of 5.
Before treatment, the allergy is confirmed by a doctor with adequate
training and experi

Charakteristika produktu

Ver 3.2
Page 1 of 14
1 PRODUCT NAME
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)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Grass pollen allergen extracts 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._ _
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 tablets.
Oralair tablet is a round, biconvex, white to beige, slightly speckled
tablet, with a diameter of 6 mm
and a radius of curvature of 5 mm, for all dose strengths.
Each tablet with a nominal mass of 100 mg
contains grass pollen allergen extract.
Two dose strengths are available:
-
100 IR
-
300 IR
Oralair 100 IR sublingual tablets are engraved 100 on each face.
Oralair 300 IR sublingual tablets are engraved 300 on each face.
The tablets cannot be halved
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Oralair is indicated for the treatment of grass pollen allergic
rhinitis with or without conjunctivitis in
adults, adolescents and children (above the age of 5) with clinically
relevant symp