Acarizax 12sq-Hdm Orally Lyophilisate 30 Tab

Product Description:

• ACARIZAX 12 SQ-HDM oral lyophilisate.

How To Use:

• For sublinguallyadministered allergy immunotherapy product.

Caution & Warnings:

Asthma:

• Asthma is a known risk factor for severe systemic allergic reactions.

Severe systemic allergic reactions:

• Treatment should be discontinued and a physician should be contacted immediately in case of severe


• Systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty in swallowing, difficulty in


• Breathing, changes in voice, hypotension or feeling of fullness in the throat. The onset of systemic symptoms


• may include flushing, pruritus, sense of heat, general discomfort and agitation/anxiety.

Oral inflammation:

• In patients with severe oral inflammation (e.g. Oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery, including dental extraction, or following tooth loss, initiation of ACARIZAX


• Treatment should be postponed and ongoing treatment should be temporarily interrupted to allow healing ofthe oral cavity.

Local Allergic Reactions:

• When treated with ACARIZAX the patient is exposed to the allergen that causes the allergic symptoms.


• Therefore, local allergic reactions are to be expected during the treatment period. These reactions are usually


• mild or moderate; however, more severe oropharyngeal reactions may occur. If the patient experiences


• significant local adverse reactions from the treatment, anti-allergic medication (e.g. antihistamines) should be considered.

Eosinophilic esophagitis:

• Isolated cases of eosinophilic esophagitis have been reported in association with ACARIZAX treatment. In patients with severe or persisting gastro-esophageal symptoms such as dysphagia or dyspepsia, medical attention must be sought.

Ingredients:

• Standardizedallergen extract fromthe house dust mitesDermatophagoides pteronyssinusandDermatophagoides farinae12 SQ-HDM* per oral lyophilisate.