ACARIZAX (American house dust mite extract and European house dust mite extract) SUBLINGUAL TABLET

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

European house dust mite extract, Quantity: 6 SQ-HDM; American house dust mite extract, Quantity: 6 SQ-HDM

Dostupné s:

Seqirus Pty Ltd

INN (Mezinárodní Name):

American house dust mite extract,European house dust mite extract

Léková forma:

Tablet

Složení:

Excipient Ingredients: Gelatin; sodium hydroxide; purified water; mannitol

Podání:

Sublingual

Jednotky v balení:

90 sublingual tablets, 10 sublingual tablets, 30 sublingual tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Allergic rhinitis ACARIZAX is indicated for the treatment of house dust mite (HDM) allergic rhinitis not well controlled despite use of symptom relieving medication in adults and adolescents (? 12 years). Allergic asthma ACARIZAX is indicated for the treatment of HDM allergic asthma not well controlled by inhaled corticosteroids and associated with HDM allergic rhinitis in adults. Patients? asthma status should be carefully evaluated before the initiation of treatment.

Přehled produktů:

Visual Identification: White to off-white freeze dried debossed sublingual tablets; Container Type: Blister Pack; Container Material: Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Licence status A

Datum autorizace:

2016-08-01

Informace pro uživatele

ACARIZAX
®
Consumer Medicine Information
Page 1 of 5
ACARIZAX
®
_(a-kari-zaks) _
American house dust mite extract and European house dust mite extract
Standardised allergen extract from house dust mites _Dermatophagoides
farinae_ and
_Dermatophagoides pteronyssinus_
_ _
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
ACARIZAX
®
. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks
and benefits. Your doctor
has weighed the risks of
you taking ACARIZAX
®
against the benefits this
medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT ACARIZAX
®
IS USED FOR
ACARIZAX
®
contains an
allergen extract from house
dust mites. It comes in a
tablet form which is
intended to be absorbed in
the body by placing it under
the tongue.
ACARIZAX
®
is for the
treatment of house dust
mite allergy that is
characterised by rhinitis
(sneezing, runny or itchy
nose, nasal congestion) in
adults and adolescents
aged 12 years and above.
It is also for the treatment of
house dust mite related
allergic asthma in adults.
ACARIZAX
®
is not
recommended for use in
children below 12 years of
age.
ACARIZAX
®
works by
increasing your immune
tolerance to house dust
mites leading to reduction in
the severity of your allergic
symptoms over time.
Before starting treatment,
the doctor will check if
ACARIZAX
®
is suitable for
you by performing the
appropriate blood and/or
skin prick tests.
ACARIZAX
®
is only
available with a prescription
from the doctor.
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
This medicine is not
expected to affect your
ability to drive a car or
operate machinery.
BEFORE YOU TAKE
ACARIZAX
®
_WHEN YOU MUST NOT _
_TAKE IT _
Do not take A

Charakteristika produktu

1
AUSTRALIAN PRODUCT INFORMATION - ACARIZAX
®
(AMERICAN HOUSE DUST
MITE EXTRACT & EUROPEAN HOUSE DUST MITE EXTRACT) SUBLINGUAL TABLET
1 NAME OF THE MEDICINE
American house dust mite extract and European house dust mite extract.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACARIZAX
®
is allergy immunotherapy.
ACARIZAX
®
sublingual tablets contain 12 SQ-HDM standardised allergen extract
from
the house dust mites (HDM) _ Dermatophagoides farinae_ and _
Dermatophagoides _
_pteronyssinus_.
The unit SQ-HDM has been defined to measure the potency of ACARIZAX
®
and is
based on a standardised amount of allergens from each species. Each
tablet contains
6 SQ-HDM _D. farinae_ and 6 SQ-HDM of _D. pteronyssinus _for a total
of 12 SQ-HDM.
ACARIZAX
®
sublingual tablets, 12 SQ-HDM also contains gelatin (fish), mannitol
and
sodium hydroxide.
3
PHARMACEUTICAL FORM
ACARIZAX
®
12 SQ-HDM is supplied as white to off-white freeze-dried debossed
sublingual tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALLERGIC RHINITIS
ACARIZAX
®
is indicated for the treatment of house dust mite (HDM) allergic
rhinitis not
well controlled despite use of symptom relieving medication in adults
and adolescents
(≥ 12 years).
ALLERGIC ASTHMA
ACARIZAX
®
is indicated for the treatment of HDM allergic asthma not well
controlled
by inhaled corticosteroids and associated with HDM allergic rhinitis
in adults. Patients’
asthma status should be carefully evaluated before the initiation of
treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with ACARIZAX
®
should be initiated by a clinician with experience in
treatment of allergies. Patients should have a confirmed clinical
history and a positive
test of house dust mite sensitization (specific IgE and/or skin prick
test) prior to
treatment.
The recommended dose for patients 12 years and above is one sublingual
tablet (12
SQ-HDM) daily.
It is recommended that the first sublingual tablet is taken under
medical supervision and
that the patient is monitored for 30 minutes, to enable discuss