ACARIZAX 12 SQ-HDM sublingual lyophilisate

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Dermatophagoides Farinae Extract; Dermatophagoides Pteronyssinus Extract

Disponible depuis:

ALK-Abello A/S

Code ATC:

V01AA03

DCI (Dénomination commune internationale):

Dermatophagoides Farinae Extract; Dermatophagoides Pteronyssinus Extract

Dosage:

12

forme pharmaceutique:

Sublingual lyophilisate

Domaine thérapeutique:

house dust mites

Statut de autorisation:

Marketed

Date de l'autorisation:

2019-11-29

Notice patient

1313-acarizax-ie-v4
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACARIZAX 12 SQ-HDM SUBLINGUAL LYOPHILISATE
For use in adults and adolescents (12-65 years of age)
Standardised allergen extract from House Dust Mites
(
_Dermatophagoides pteronyssinus_
and
_Dermatophagoides farinae_
)
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 ACARIZAX is and what it is used for
2.
What you need to know before you take ACARIZAX
3.
How to take ACARIZAX
4.
Possible side effects
5.
How to store ACARIZAX
6.
Contents of the pack and other information
1.
WHAT ACARIZAX IS AND WHAT IT IS USED FOR
ACARIZAX contains an allergen extract from house dust mites. It comes
in a form known as sublingual
lyophilisates, which are like tablets but much softer and absorbed
into the body by putting them under the
tongue.
ACARIZAX is used to treat allergic rhinitis (inflammation of the
lining of the nose) in adults and
adolescents (12-65 years of age) and related allergic asthma, caused
by house dust mites in adults (18-65
years of age). ACARIZAX works by increasing the immunological
tolerance (your body's ability to cope) to
house dust mites. The treatment may need to be taken for 8 to 14 weeks
before you notice any improvement.
The doctor will check your allergic symptoms and do a skin prick test
and/or take a blood sample in order to
decide if ACARIZAX is a suitable treatment for you.
The first dose of ACARIZAX should be taken under medical supervision.
You should stay under medical
observation for at least half an hour after takin

Résumé des caractéristiques du produit

Health Products Regulatory Authority
16 May 2023
CRN00DHN6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ACARIZAX 12 SQ-HDM sublingual lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Standardised allergen extract from the house dust mites
_Dermatophagoides pteronyssinus _and_ Dermatophagoides farinae _12
SQ-HDM* per sublingual lyophilizate.
For a full list of excipients, see section 6.1
* [SQ-HDM is the dose unit for ACARIZAX. SQ is a method for
standardisation on biological potency, major allergen content
and complexity of the allergen extract. HDM is an abbreviation for
house dust mite.]
3 PHARMACEUTICAL FORM
Sublingual lyophilisate
White to off-white circular freeze-dried debossed sublingual
lyophilisate
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACARIZAX is indicated in adult patients (18-65 years) diagnosed by
clinical history and a positive test of house dust mite
sensitisation (skin prick test and/or specific IgE) with at least one
of the following conditions:

persistent moderate to severe house dust mite allergic rhinitis
despite use of symptom-relieving medication

house dust mite allergic asthma not well controlled by inhaled
corticosteroids and associated with mild to severe
house dust mite allergic rhinitis. Patients' asthma status should be
carefully evaluated before the initiation of
treatment (see section 4.3).
ACARIZAX is indicated in adolescents (12-17 years) diagnosed by
clinical history and a positive test of house dust mite
sensitisation (skin prick test and/or specific IgE) with persistent
moderate to severe house dust mite allergic rhinitis despite use
of symptom-relieving medication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults and adolescents (12-17 years) is one
sublingual lyophilisate (12 SQ-HDM) daily.
Onset of the clinical effect is to be expected 8-14 weeks after
initiation. International treatment guidelines refer to a treatment
period of 3 years for allergy immunotherapy to achieve disease