ACTAIR Initiation Treatment 100IR & 300IR sublingual tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

European house dust mite, Quantity: 150 IR; American house dust mite, Quantity: 150 IR

Available from:

Stallergenes Australia Pty Ltd

INN (International Name):

American house dust mite,European house dust mite

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Sublingual, Oral

Units in package:

3 sublingual tablets of 100 IR + 88 sublingual tablets of 300 IR, 3 sublingual tablets of 100 IR + 7 sublingual tablets of 300 IR, 3 sublingual tablets of 100 IR + 28 sublingual tablets of 300 IR

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of house dust mite allergic rhinitis with or without conjunctivitis in adults, adolescents and children 5 years and over diagnosed with house dust mite allergy.

Product summary:

Visual Identification: White to beige, round and biconvex, brown speckled tablets engraved with SAC on one side and 300 on the other 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

Authorization status:

Licence status A

Authorization date:

2016-04-15

Patient Information leaflet

ACTAIR 100IR and 300IR Sublingual Tablets V2.4
1
ACTAIR
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ACTAIR?
ACTAIR contains active ingredients which are a 50% mixture of allergen
extracts from 2 species of house dust mite- American
House Dust Mite and European House Dust Mite. ACTAIR is used for the
treatment of house dust mite 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 5 years and over
For more information, see Section 1. Why am I using ACTAIR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACTAIR?
Do not use if you have ever had an allergic reaction to any of the
ingredients listed at the end of the CMI or if you suffer from
severe and/or unstable asthma; your immune system is very weakened; if
you suffer from a cancer; if you have any
inflammation in your mouth
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use ACTAIR?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ACTAIR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE ACTAIR?
The therapy is composed of an initiation treatment (including a 3-day
dose escalation) and a continuation treatment.
The tablets are taken by keeping the tablet under your tongue until it
is completely disintegrated (at least 2 minutes) before
you swallow. More instructions can be found in Section 4. How do I use
ACTAIR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACTAIR?
THINGS YOU SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
ACTAIR.
You are advised to

Summary of Product characteristics

Version 2.4
1
AUSTRALIAN
PRODUCT
INFORMATION
–
ACTAIR®
(MIXTURE
OF
AMERICAN (D. FARINAE) AND EUROPEAN (D. PTERONYSSINUS) HOUSE
DUST MITE ALLERGEN EXTRACTS) SUBLINGUAL TABLETS
1
NAME OF THE MEDICINE
ACTAIR Initiation Treatment Sublingual Tablets 100 IR & 300 IR
Mixture of American (_D. farinae_) and European (_D. pteronyssinus_)
House dust mite allergen extracts.
ACTAIR Continuation Treatment Sublingual Tablets 300 IR
Mixture of American (_D. farinae_) and European (_D. pteronyssinus_)
House dust mite allergen extracts
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
A
50%
mixture
of
House
dust
mite
allergen
extracts
from:
European
house
dust
mites
(_Dermatophagoides pteronyssinus_) and American house dust mites
(_Dermatophagoides farinae_), 100
IR* or 300 IR* per sublingual tablet.
* IR (Index of Reactivity): The IR unit 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.
Excipients with known effects: Lactose monohydrate
One sublingual tablet of 100 IR contains 82.8 – 83.3 mg Lactose
monohydrate.
One sublingual tablet of 300 IR contains 80.8 – 82.3 mg Lactose
monohydrate
FOR FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Sublingual tablet.
ACTAIR is presented as white to beige, brown speckled tablet. The 100
IR tablets are engraved “SAC”
on one side and “100” on the other and the 300 IR tablets are
engraved ”SAC” on one side and “300”
on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of house dust mite allergic rhinitis with or without
conjunctivitis in adults, adole