ACARIZAX TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE

Disponible depuis:

ALK-ABELLO A/S

Code ATC:

V01AA03

DCI (Dénomination commune internationale):

HOUSE DUST MITES

Dosage:

6UNIT; 6UNIT

forme pharmaceutique:

TABLET

Composition:

DERMATOPHAGOIDES PTERONYSSINUS 6UNIT; DERMATOPHAGOIDES FARINAE 6UNIT

Mode d'administration:

SUBLINGUAL

Unités en paquet:

10

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ALLERGENIC EXTRACTS

Descriptif du produit:

Active ingredient group (AIG) number: 0223339003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-05-04

Résumé des caractéristiques du produit

_Product Monograph Master Template _
_Template Date: September 2020 _
_ACARIZAX_
_®_
_ Standardized Allergen Extract, House Dust Mites (D. farinae and D.
pteronyssinus) _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ACARIZAX®
Standardized Allergen Extract, House Dust Mites (_D. farinae and D.
pteronyssinus_)
Sublingual Tablet, 12 SQ-HDM
Allergy Immunotherapy
Therapeutic classification: Allergen extracts, house dust mite
ATC code: V01AA03
ALK-Abelló A/S
Bøge Allé 6-8
2970 Hørsholm
Denmark
http://www.alk.net
Date of Initial Authorization:
May 04, 2017
Date of Revision:
December 29, 2022
Submission Control Number: 241617
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_ACARIZAX_
_®_
_ Standardized Allergen Extract, House Dust Mites (D. farinae and D.
pteronyssinus) _
_Page 2 of 30_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended D