ACARIZAX Oral lyophilisate (2021)
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Περιεχόμενα
1. Name of the medicinal product
ACARIZAX 12 SQ-HDM oral lyophilisate.
2. Qualitative and quantitative composition
Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae 12 SQ-HDM<sup>*</sup> per oral lyophilisate. For a full list of excipients, see section ...
3. Pharmaceutical form
Oral lyophilisate. White to off-white circular freeze-dried debossed oral lyophilisate.
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 ...
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 ...
4.3. Contraindications
Hypersensitivity to any of the excipients (for a full list of excipients, see section 6.1). Patients with FEV<sub>1</sub> <70% of predicted value (after adequate pharmacological treatment) at initiation ...
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 ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction trials have been conducted in humans and no potential drug interactions have been identified from any source. Concomitant therapy with symptomatic anti-allergic medications may increase ...
4.6. Fertility, pregnancy and lactation
Pregnancy There is no data on the clinical experience for the use of ACARIZAX in pregnant women. Animal studies do not indicate increased risk to the foetus. Treatment with ACARIZAX should not be initiated ...
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.
4.8. Undesirable effects
Summary of the safety profile Subjects taking ACARIZAX should primarily expect mild to moderate local allergic reactions to occur within the first few days and subsiding again with continued treatment ...
4.9. Overdose
In phase I studies adult patients with house dust mite allergy were exposed to doses up to 32 SQ-HDM. No data are available in adolescents regarding exposure to doses above the recommended daily dose of ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Allergen extracts, house dust mite <b>ATC code:</b> V01AA03 Mechanism of action ACARIZAX is allergy immunotherapy. Allergy immunotherapy with allergen products is the ...
5.2. Pharmacokinetic properties
No clinical studies investigating the pharmacokinetic profile and metabolism of ACARIZAX have been conducted. The effect of allergy immunotherapy is mediated through immunological mechanisms, and there ...
5.3. Preclinical safety data
Conventional studies of general toxicology and toxicity to reproduction in mice have revealed no special hazards to humans.
6.1. List of excipients
Gelatine (fish source) Mannitol Sodium hydroxide (for pH adjustment)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Aluminium/aluminium blister cards in outer carton. Each blister card contains 10 oral lyophilisates. <u>Pack sizes:</u> 30 and 90.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
ALK-Abelló A/S, Bøge Alle 6-8, DK-2970 Hørsholm, Denmark
8. Marketing authorization number(s)
PL10085/0058
9. Date of first authorization / renewal of the authorization
17/5/2021
10. Date of revision of the text
17/5/2021
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