Special Warning : אזהרת שימוש

4.4            Special warnings and precautions for use
Asthma
Asthma is a known risk factor for severe systemic allergic reactions.
Patients should be advised that ACARIZAX is not intended to treat acute asthma exacerbations. In the event of an acute asthma exacerbation, a short-acting bronchodilator should be used. If patients find short-acting bronchodilator treatment ineffective or they need more inhalations than usual, medical attention must be sought.
Patients must be informed of the need to seek medical attention immediately if their asthma deteriorates suddenly.
ACARIZAX should initially be used as add on therapy and not as a substitute of pre-existing asthma medication. Abrupt discontinuation of asthma controller medication after initiation of ACARIZAX treatment is not recommended. Reductions in asthma controller medication should be performed gradually under the supervision of a physician according to asthma management guidelines.
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.
One option for treating severe systemic allergic reactions is adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants, mono amino oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers.
Patients with cardiac disease may be at increased risk in case of systemic allergic reactions. Clinical experience in treatment with ACARIZAX of patients with cardiac disease is limited.
This should be taken into consideration prior to initiating allergy immunotherapy.
Initiation of ACARIZAX in patients who have previously had a systemic allergic reaction to subcutaneous house dust mite immunotherapy should be carefully considered, and measures to treat potential reactions should be available. This is based on post-marketing experience from a corresponding sublingual tablet product for grass pollen immunotherapy which indicates that the risk of a severe allergic reaction may be increased for patients who have previously experienced a systemic allergic reaction to subcutaneous grass pollen immunotherapy.
The physician may consider prescribing auto-injectable adrenaline prescription for patients who have experienced a systemic reaction to immunotherapy in the past. Patients who are prescribed adrenaline while receiving immunotherapy should be instructed in the procedure of emergency self-injection of adrenaline.
Instruct patients to seek immediate medical care upon use of auto-injectable adrenaline and to stop treatment with ACARIZAX.
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 of the 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 oesophagitis
Cases of eosinophilic oesophagitis have been reported in association with ACARIZAX treatment. In patients with severe or persisting gastro-oesophageal symptoms such as dysphagia or dyspepsia, ACARIZAX should be interrupted and medical evaluation must be sought.
Autoimmune diseases in remission
Limited data is available on treatment with allergy immunotherapy in patients with autoimmune diseases in remission. ACARIZAX should therefore be prescribed with caution in these patients.
Food allergy
ACARIZAX may contain trace amounts of fish protein. Available data have not indicated an increased risk of allergic reactions in patients with fish allergy.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7            Effects on ability to drive and use machines
Treatment with ACARIZAX has no or negligible influence on the ability to drive or use machines.