ACTAIR 100 IR & 300 IR sublingual tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dermatophagoides Pteronyssinus Extract; Dermatophagoides Farinae Extract

Available from:

STALLERGENES

ATC code:

V01AA03

INN (International Name):

Dermatophagoides Pteronyssinus Extract; Dermatophagoides Farinae Extract

Dosage:

100 & 300 Index of Reactivity

Pharmaceutical form:

Sublingual tablet

Therapeutic area:

house dust mites

Authorization status:

Not marketed

Authorization date:

2021-10-08

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTAIR 100 IR & 300 IR SUBLINGUAL TABLETS
FOR USE IN ADOLESCENTS AND ADULTS (12-65 YEARS OF AGE)
Standardised House Dust Mite Allergen Extracts
(_Dermatophagoides pteronyssinus_ and _Dermatophagoides farinae_)
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ACTAIR is and what it is used for
2.
What you need to know before you take ACTAIR
3.
How to take ACTAIR
4.
Possible side effects
5.
How to store ACTAIR
6.
Contents of the pack and other information
1.
WHAT ACTAIR IS AND WHAT IT IS USED FOR
ACTAIR contains allergen extracts from house dust mites.
ACTAIR is used to treat allergic rhinitis (inflammation of the lining
of the nose) in adolescents (12-17
years of age) and adults. ACTAIR works by increasing the immunological
tolerance to (your body's ability
to cope with) house dust mites. The treatment may need to be taken for
3 months before you notice
any improvement.
ACTAIR 100 IR is intended only for the dose escalation period and not
for maintenance.
Before starting the treatment, your allergy will be diagnosed by a
doctor who will perform the
appropriate skin and/or blood tests.
The first dose of ACTAIR should be taken under medical supervision.
You should stay under medical
observation for at least half an h

Summary of Product characteristics

Health Products Regulatory Authority
21 April 2023
CRN00DJGK
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
ACTAIR 100 IR & 300 IR sublingual tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Standardised house dust mite allergen extracts from: _Dermatophagoides
pteronyssinus_ and _Dermatophagoides farinae_ in equal
parts, 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.
Excipient with known effect
Each sublingual tablet of 100 IR contains 82.8 – 83.3 mg of lactose
monohydrate.
Each sublingual tablet of 300 IR contains 80.8 – 82.3 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual tablet.
The tablets of 100 IR are white to beige, round and biconvex, brown
speckled, engraved "SAC" on one side and "100" on the
other.
The tablets of 300 IR are white to beige, round and biconvex, brown
speckled, engraved "SAC" on one side and "300" on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACTAIR is indicated in adolescents (12-17 years) and adults for
treatment of moderate to severe house dust mite-induced
allergic rhinitis or rhinoconjunctivitis, diagnosed by clinical
history and a positive test of house dust mi