ACARIZAX

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

DERMATOPHAGOIDES FARINA; DERMATOPHAGOIDES PTERONYSSINUS

Dostupné z:

TRUPHARM MARKETING 1985 LTD.

ATC kód:

V01AA03

Forma lieku:

TABLETS

Zloženie:

DERMATOPHAGOIDES PTERONYSSINUS 6 SQ-HDM; DERMATOPHAGOIDES FARINA 6 SQ-HDM

Spôsob podávania:

SUBLINGUAL

Typ predpisu:

Required

Výrobca:

ALK- ABELLÓ A/S, DENMARK

Terapeutické oblasti:

HOUSE DUST

Terapeutické indikácie:

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.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.

Dátum Autorizácia:

2020-10-19

Príbalový leták

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ACARIZAX
TABLETS FOR USE UNDER THE TONGUE
ACTIVE INGREDIENTS: Standardized allergen extract from house dust
mites 12
SQ-HDM
_Dermatophagoides pteronyssinus_ 6 SQ-HDM
_Dermatophagoides farinae _6 SQ-HDM_ _
Inactive ingredients and allergens: see section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have any further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
ACARIZAX is prescribed in special clinics by allergy and immunology
specialists.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
ACARIZAX is used to treat adults (18-65 years of age) who have been
diagnosed
based on their medical history and whose skin prick tests for house
dust mite were
found positive and who have at least one of the following conditions:
•
persistent, moderate to severe allergic rhinitis, caused by house dust
mite
allergy despite medication to relieve symptoms.
•
allergic asthma, caused by house dust mite, that is not well
controlled with
corticosteroid inhalers, and is associated with mild to severe
allergic rhinitis.
Severity of the patient’s asthma must be carefully diagnosed before
starting
treatment.
ACARIZAX is used to treat adolescents (12-17 years of age) whose skin
prick tests
for house dust mite were found positive and who have been diagnosed
based on
their medical history with persistent moderate to severe allergic
rhinitis, despite
medication to relieve symptoms.
THERAPEUTIC GROUP: allergen extract from house dust mites.
ACARIZAX works by increasing the immunological tolerance (your body's
ability to
cope with) to house dust mites. You may need to take the treatment for
8 to 14
weeks before you notice any i

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ACARIZAX
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Standardised allergen extract from the house dust mites
_Dermatophagoides pteronyssinus _6 SQ-HDM* and_ _
_Dermatophagoides farina 6 _SQ-HDM*.
12 SQ-HDM* per sublingual lyophilisate tablet
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 tablet
White to off-white circular freeze-dried debossed sublingual
lyophilisate tablet
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 (ACARIZAX)
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 trea