ORALAIR Initiation Treatment, Sublingual (Allergen pollen Extract of 5 grasses) Tablets 100IR & 300IR Blister Pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Lolium perenne, Quantity: 20 %; Phleum pratense, Quantity: 20 %; Anthoxanthum odoratum, Quantity: 20 %; Dactylis glomerata, Quantity: 20 %; Poa pratensis, Quantity: 20 %

Dostopno od:

Stallergenes Australia Pty Ltd

INN (mednarodno ime):

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

Farmacevtska oblika:

Tablet

Sestava:

Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; lactose monohydrate

Pot uporabe:

Sublingual

Enote v paketu:

Sample pack size: Blister of 1 x 3 100 IR tablets and a blister of 1 x 7 300 IR tablets, Blister of 1 x 3 100 IR tablets, Blister of 1 x 28 300 IR tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

Visual Identification: Round, biconvex, white to beige, slightly speckled tablet, engraved 100 on each side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2011-05-03

Navodilo za uporabo

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

Lastnosti izdelka

Version 4.6
1
AUSTRALIAN PRODUCT INFORMATION – ORALAIR (ALLERGEN
POLLEN EXTRACT OF 5 GRASSES) TABLETS
1
NAME OF THE 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)
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 List of excipients.
3
PHARMACEUTICAL FORM
Sublingual tablets.
Oralair is presented as a slightly speckled, white to beige tablet.
The 100 IR tablet has 100
engraved on both sides and the 300 IR tablets have 300 engraved on
both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 pollen.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be initiated each year about 4 months