Actair 300 IR Continuation treatment sublingual tablets

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dermatophagoides farinae allergen extract 150 IR ((American house dust mite)); Dermatophagoides pteronyssinus allergen extract 150 IR ((European house dust mite))

Available from:

Stallergenes Greer New Zealand Ltd

INN (International Name):

Dermatophagoides farinae allergen extract 150 IR ((American house dust mite))

Dosage:

300 IR

Pharmaceutical form:

Sublingual tablet

Composition:

Active: Dermatophagoides farinae allergen extract 150 IR ((American house dust mite)) Dermatophagoides pteronyssinus allergen extract 150 IR ((European house dust mite)) Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Prescription type:

Prescription

Manufactured by:

Stallergenes

Therapeutic indications:

ACTAIR is indicated for the 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:

Package - Contents - Shelf Life: Blister pack, containing 300 IR tablets - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, containing 300 IR tablets - 90 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2015-02-16

Patient Information leaflet

ACTAIR 100IR and 300IR Sublingual Tablets V3.0
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

New Zealand DATA SHEET
ACTAIR 100 IR and 300 IR sublingual tablets
V3.0
Page
1
of
14
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
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
sublingual tablet is a round, biconvex, white to beige, brown 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 house dust mites
allergen extract (50% mixture
from European house dust mites and American house dust mites).
Two dose strengths are available:
-
100 IR
-
300 IR
ACTAIR 100 IR sublingual tablets are engraved “SAC” on on