Acarizax 12 SQ-HDM Oral Lyophilisate Tablet

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Der far extract (Dermatophagoides farinae); Der pte extract (Dermatophagoides pteronyssinus)

Inapatikana kutoka:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Jina la Kimataifa):

Der far extract (Dermatophagoides farinae); Der pte extract (Dermatophagoides pteronyssinus)

Vitengo katika mfuko:

10 Tablets; 30 Tablets

Viwandani na:

Catalent UK Swindon Zydis Limited

Taarifa za kipeperushi

Abbott Laboratories (M) Sdn. Bhd.
27-02, Level 27, Imazium,
No. 8, Jalan SS 21/37,
Damansara Uptown,
47400 Petaling Jaya,
Selangor Darul Ehsan, Malaysia
12/04/2022

Tabia za bidhaa

1
NAME OF THE MEDICINAL PRODUCT
ACARIZAX
®
12 SQ-HDM oral lyophilisate tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Standardised allergen extract from the house dust mites 12 SQ-HDM* per
oral lyophilisate
6 SQ-HDM
_Dermatophagoides pteronyssinus _
6 SQ-HDM
_Dermatophagoides farinae _
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
Oral lyophilisate
White to off-white freeze-dried debossed oral 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
oral 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 modification. Efficacy
data is available for 18 months of treatment with ACARIZAX
®
in adults; no data is